Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Reason
When registering the patient's name on the acuson sc2000 ultrasound system, case / patient differences are considered when describing the patient name. if the differences are not corrected at registration, the system will not capture the images or clips with a potential risk that the study data, including the measurements, will not be captured and the study must be performed again, extending the examination time to reacquire missing data.
Action
Software update. Action code US030 / 15 / S and US031 / 15 / S. //////////// Recommendation to users and patients: the user should file all patient data before the software update starts. ///////// In addition, while updating software is not performed, the recommendation of Portuguese Letter US024 / 15 / S is maintained, which says: in order to avoid the problem of registering the patient's name, the user must correct the differences in uppercase / lowercase letters in the patient's name at the time of registration.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
The company made a potential risk assessment and concluded that packaging adhesion is unlikely to cause an adverse effect on the patient or even the implant. As reported by the company, if wear particles generated from the film / adhesion residue of LDPE packaging were expected to elicit similar biological reactions from those of ultra high molecular weight polyethylene and are unlikely to increase the possibility of peri-prosthetic osteolysis .
Reason
Some components of highly polished implants were packed in a low density polyethylene (ldpe) casing with the potential to adhere to the implants.
Action
Pick up and return to the manufacturer. Action code FAM-03. The distributors must carry out the traceability of the products in their inventory. When you find products related to lots of this field action, it segregates them. The company will collect the affected units.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
According to the registry holder, there are no negative impacts related to the patient, because the breaks occurred in the rod near the cable, externally to the patient, without the production of debris. There are also no risks related to lack of surgery, as the manufacturer also offers a series of "monobloc" lumbar distractors (HRCIDx / x references) that can be used instead of the instruments used for this recall.
Reason
According to the record holder there may be breakage of the cable of two surgical instruments that may have been caused by the soldering point or deviations in its form of use.
Action
Pick up and return to the manufacturer. Action code: 00003. It is recommended to stop immediately the use of the affected products and their segregation, with subsequent return to the importer; the importer will be responsible for returning the instruments affected to the manufacturer, as well as the replacement of the items collected to the customers. It is also recommended that any adverse events noted should be reported to the importer and to the competent health authority.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
0
Reason
According to the single sample tax analysis report no. 115.105980, issued by the central laboratory of public health professor gonçalo moniz of the health secretariat of the state of bahia, the product bag for collection of blood cpda1, brand fresenius kabi, validity 10 / 2016, lot 71hl07aa00-04 was considered unsatisfactory in the appearance assay (presence of foreign body).
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Extra notes in the data
Action
Supplementing the safety note (FA-Q118-MCS-1) from Abbott regarding the HeartMate 3 System for Left Chamber Assistance, cat. No. 106524INT - LVAS HM3 kit
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
Cases reported as serious adverse events resulted in surgical interventions and, in one case, the patient died after the operation due to severe comorbidities. After investigating the case, Abbott Vascular has determined that a chuck fracture may occur if stress is exerted on the Single-Directional Knob to implant the Clip. Tension occurs if the Arm Positioner is not in Neutral position during clip release.
Reason
Nine case reports related to the single-directional pushbutton clip delivery system device (batch number 50714u1 and above) according to which the user attempted to deploy a mitraclip but could not remove the clip from the delivery system due to a fracture in the mandrel. the chuck is an internal component of the clip delivery system, integral to the operation and deployment of the clip. after investigating the case, abbott vascular has determined that a chuck fracture may occur if stress is exerted on the single-directional drive knob to implant the clip.
Action
Safety notice. Change of Instructions for Use. Action Code: February 4, 2016. As long as the user follows the procedure described in the revised instructions for use contained in the notice of this field action, there are no consequences for the use of products at risk. It should be noted that in addition to this statement, Abbott Vascular has a trained professional to follow all the procedures that involve the use of the product in Brazil, ensuring the correct use by the physician, according to the new instructions.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
The product has a problem with its secondary packaging.
Reason
Defect in the packaging seal, which can potentially lead to non-sterility of the product.
Action
Pick up and return to the manufacturer. Action code: RA 2015-172. Products that are still in stock, in the possession of distributors and / or hospitals must be returned to Stryker do Brasil.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
The recall was performed because it could cause potential serious adverse events.
Reason
There may be separation of the catheter tip, which may lead to loss of device function and obstruction of blood flow to terminal organs.
Action
Gathering and destruction. Action code T10071-36 and T10071-37. The manufacturer directs not to use the product and to communicate the company as soon as possible so that the necessary measures are taken.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
The Brazilian population is very heterogenous, and some specific population groups have distinct variants of Anti-RH5, which can lead to some false negative results when using the product. As these cases are very rare, it is difficult to identify them, the company in becoming aware of this possibility, is suggesting the use of a complementary method for the identification of this antigen.
Reason
Fresenius kabi has identified a divergence in the results of some samples of the duolys and phenolys products, which are used for phenotyping the rh + k system in laboratories and blood banks in the freelys nano and qwalys equipment. we have noticed that some samples of the product have failed to detect the antigen "e" (one of the antigens that is part of the kit profile). clones of the anti-and impregnated monoclonal reagent in the wells of these microplates are ms63 and p3gd512.
Action
Availability of a reagent Soroclone Anti-e, of monoclonal origin, for tube testing. Action code: 01-2016. As a preventive measure, the phenotype is repeated for the antigen "e", in all cases where the result obtained in the microplate is negative for said antigen. For this, Fresenius Kabi will be supplying, together with the DuoLys and PhenoLys kits, the monoclonal reagent Soroclone Anti-e, for tube testing, prepared from clones MS26 + MS21 + MS63.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
The potential risk associated with attempting to proceed with coaxial placement, using the sharpened stylus rather than the optional blunt tip stylus, may be variable depending on the anatomical location of the biopsy and may cause an additional unintended risk to tissue, vessels and other organs. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
Reason
The coaxial biopsy needle may inadvertently have a blunt-tipped stylet of incorrect size that will not pass through the coaxial. specifically the product should contain a blunt tip stylus of 19 gauge and actually contains a 17 gauge stylus.
Action
Gathering and destruction. Evaluate inventory and do not use or distribute any affected product. If the affected product has been safely used, no further action is required.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
Recommendations for users and patients: DO NOT USE Eclipse versions 11, 13, 13.5 or 13.6 with the PBC 11.0.31 algorithm for conventional arc field dose calculation. #### UPDATED ON 10/25/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
Reason
An anomaly was identified with the eclipse three-dimensional planning system using pbc 11.0.31 to calculate a conventional arcuate dose distribution. when using pbc 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments with eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the monitor units ( mu) calculated. potential for unintentional radiation exposure.
Action
Action code CP-23187. Varian Medical Systems Brazil has sent a Letter of Safety dated January 11, 2016 to all affected customers. The letter describes affected models, problem and necessary actions, among them the software update. For customer questions related to this help desk action of Varian Telephone: + 1-888-827-4265; E-mail: support@varian.com
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
In case the needle is not cut, the user may experience greater discomfort and pain during puncture of the peripheral access.
Reason
Blunt needle proven for results out of product specification.
Action
Gathering and destruction. Action code 02-2016. In this case, it is recommended not to use the product and to contact the company for collection and replacement of the bags.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
The analysis was carried out by the Instituto Adolfo Lutz (IAL) and did not verify inviolability of the packaging and there was no characterization of the foreign body. Nonconformity occurred in a single unit. IAL was asked to sample the product or images for evaluation by the company.
Reason
Precautionary interdiction of the lot described by covisa-sp as a result of the presence of a foreign body in the inviolate packaging of the material.
Action
The company requests the collection of the quantity in stock in the customers and segregation of the target products of the field action until new measures are taken. Send the company the quantitative data raised.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
Reinforce the need for users NOT to use the hand-held level regulator in therapy and DO NOT perform any SN / CO single puncture therapy before certifying the perfect operation of the Dialog + SW 9.xx manual level regulator.
Reason
By means of investigations by the registry holder, b. braun s / a, the possibility of reversing the positioning of the tubes between the valve block of the level regulator system and the diaphragm pump was identified. this occurs during any technical intervention or maintenance measures if the functionality of this level regulator system is not properly tested as required in the service manual. this can occur during any repair or maintenance activity where it is necessary to disconnect and reconnect the tubes, which results in reversing the function of the manual level control system.
Action
Action code AC / 03/2015. Elaboration of Message Letter with Security Alert dated 04/4/2015 and delivery to each client involved //// Receipt of Receipt Confirmations of the Message Letter //// Correction in the field for the applicable cases through Correction of parts.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
Do not use or distribute products involved in this recall. Return the product to your supplier / distributor so that the correct treatment is carried out (destruction of the material or return to the manufacturer - awaiting decision). Politec Importacao e Comércio Ltda., Is taking all applicable measures to avoid any inconvenience that may arise from this recall voluntarily initiated by Sage Products Inc .. For any information or clarification on this subject, Milena Raizer (recallsage@politecsaude.com.br) or by phone 11 - 99690-4626. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Reason
Potential contamination of certain lots of the product by the bacterium burkholderia cepacia. according to sage products inc., topical administration of the potentially contaminated product may, under certain circumstances, cause infections in immunocompromised users and inpatients, as well as in other patient groups.
Action
Action of Field nº 142/16 triggered under the responsibility of the company Politec Importação e Comércio LTDA. Classification of risk: II Classification of the field action: Recollection; Undoing. Direct communication through letter, email and / or telephone to customers and / or distributors for voluntary recall notice. In case client / distributor still have units in stock, such units should return to Politec Saúde for correct final disposal. Politec Importação e Comércio Ltda., Will arrange the voluntary collection of this product, fulfilling us contact V. Sa. in order to inform about this recall and the temporary suspension of product supply. The subject of this recall includes different lot numbers as indicated in the table below, noting that batches received by V. Sa. are the ones mentioned in the body of the email. In view of this recall and given the procedures stipulated by regulatory agencies, among other provisions also applied, we require that you. take the following measures: 1) Cease the use and distribution of batches of listed products 2) Complete the attached acknowledgment report, sign it and send it immediately to recallsage@politecsaude.com.br. This will allow confirmation of receipt of this notification and also confirmation of the quantity of this product in your hands. 3) If you have in stock for resale, consumption or any other purpose any batches of the product subject to such recall segregate it. The form of compensation through credit or exchange will be informed in a timely manner. 4) As a distributor or reseller of our products, we require you to inform us who has or has shipped the product on screen. Please use the enclosed worksheet.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
Users should ensure that those responsible for maintaining the equipment use the latest version of the Service Manual to maintain the safe and adequate performance of medical equipment. Users may continue to use Lightspeed CT, Discovery ST PET CT or Discovery LS PET CT systems. If maintenance of the system is performed by GE Healthcare, GE has confirmed that no further action is required on the power supply; however, users should update the Service Manual as instructed in the Urgent Security Notice Letter, attached to this form, in the "Product Fix" section. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client and replacement parts.
Reason
Ge has updated the service manuals for the products mentioned in this notice to correct an incorrect torque value. this field action is to inform customers about this update. the service manual update was performed due to the maintenance procedure, which describes replacing the power supply on the rotating side of the gantry, specifying an incorrect torque value on the mounting hardware. due to this error, the three fastening screws that attach to the power supply may have excess torque if the power supply has been replaced in the system.
Action
a) Risk Classification: CLASS III - Situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences. b) Classification of Field Action: Other. Specify: Send letter with instructions for updating the Service Manual. c) Field Action Code: IMF 25467 d) Recommendations to Users and Patients: Users should ensure that those responsible for maintaining the equipment use the latest version of the Service Manual to maintain the safe and adequate performance of medical equipment. Users may continue to use Lightspeed CT, Discovery ST PET CT or Discovery LS PET CT systems. If maintenance of the system is performed by GE Healthcare, GE has confirmed that no further action is required on the power supply; however, users should update the Service Manual as instructed in the Urgent Security Notice Letter, attached to this form, in the "Product Fix" section.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
This problem was observed by GE Healthcare of Brazil in various coil configurations and port connections. To avoid this problem, follow the user's instructions on proper use of the pad to avoid all direct patient contact with the cable. The system may continue to be used. The user should ensure the following precautions as described in the GEM Flex 3.0T User Manual: - Placing the foam cover over the Interface. - Do not let the cable contact the patient. Use the cushion to prevent the cable from touching the patient. - Keep the shortest cable length in the gantry. - Use the system only in adult patients. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.
Reason
On december 18, 2015, ge became aware of a safety problem related to the gemflex 3.0t coil, manufactured by neocoil, used in ge healthcare's 3.0t magnetic resonance equipment. part of the cable assembly may overheat while using the device. the occurrence of this problem could result in a burn, which according to the holder of the record is of minimal degree, in the case of prolonged contact of the skin with the superheated part.
Action
IMF Action Code 60891. Notification to Customers-Delivery of Urgent Security Notice Letters issued on 02/25/2016 /// Recommendations to Users and Patients: To avoid this problem, follow the user's instructions on proper use of the cushion (pad), to avoid any direct contact of the patient with the cable. The system may continue to be used. The user should ensure the following precautions as described in the GEM Flex 3.0T User Manual: - Placing the foam cover over the Interface. - Do not let the cable contact the patient. Use the cushion to prevent the cable from touching the patient. - Keep the shortest cable length in the gantry. - Use the system only in adult patients. //// Field Correction - Parts and Parts Correction .///// If you have questions about this action or the identification of the affected items, please contact your local GE Healthcare Sales or Service representative. Please call the following number: 0800-122345
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
The company that registers in Brazil notes: "It is recommended that all users of Pentax ED-3490TK videoduodenoscopes follow strictly the new instructions and procedures for high-level cleaning and disinfection included in the reprocessing and up-to-date operation manual. The updated reprocessing manual should be fully read by users and any questions or concerns should be immediately forwarded to Pentax Medical Brazil, its field technicians and / or regulatory affairs department, to ensure that all recommendations are clearly understood and in this way reduce the risk of contamination during ERCP / ERCP procedures. "
Reason
In 2015 the fda issued a public safety notice informing of the potential association between duodenoscopes and incident reports on ercp cholangiopancreatography procedures associated with the presence of multiresistant bacteria in patients undergoing this procedure in a few institutions in the united states. since then pentax in conjunction with the fda, medical societies and healthcare professionals, has updated and validated reprocessing instructions for the ed-3490tk duodenoscope model.
Action
After learning of these adverse events and the FDA safety communication, to inform health professionals about the potential association between duodenoscopes and incident reports during ERCP / ERCP in some hospitals in the United States, Pentax has been working with the FDA, as part of an industry initiative to determine what additional steps, if necessary, could be taken to reduce the risk of infection in flexible endoscopes used for ERCP / ERCP. Pentax has conducted tests to increase the safety margin associated with reprocessing of the ED-3490TK duodenoscope. In Brazil on 12/8/2015 Pentax Medical Brazil responded to Anvisa notification No.79 / 2015 / GEAAR / GGMON / ANVISA, indicating that upon completion of these tests it could provide a new reprocessing manual and instructions for all who purchased the duodenoscope Pentax model ED-3490TK. Field actions involve the following procedures: 1- Translate the new Pentax reprocessing and operation manual into Portuguese. 2- Communicate and send to all users of the ED-3490TK, the new reprocessing and operation manual, containing the new instructions for use, reprocessing, cleaning, disinfection and sterilization. 3- Perform reprocessing and cleaning training for all users who have purchased the ED-3490TK to ensure these instructions are understood.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
On 04/4/2016 - UPDATE: Users must comply with the guidelines made by the registration company, complete and return the Response Form, in order that the registration holder can implement the activities provided for in said Field Action.
Reason
Olympus worked with the us food and drug administration (fda) to mitigate the risk of infection following endoscopic ercp procedures that used the tjf-q180v. the fda was concerned about the potential leakage of a patient's fluids or materials through the sealing mechanism, the tweezer lift, and asked olympus to tighten the mechanism. since the launch of the product in question in may 2010, there has been no reported case of an infection occurring after an ercp using the tjf-q180v, due to o-ring leakage from the tweezers lift. however, olympus made the following design upgrades related to the tweezer lift sealing mechanism in order to reduce the chances of a potential leak: a) narrowed dimensional tolerances of the mechanical parts related to the sealing mechanism. b) narrowed dimensional tolerances and hardness for the o-rings. then, the fda approved the "design" changes above. in addition, through communications with the fda, olympus has decided to do so. mainly, the following labeling changes: 1) return the tjf-q180v to an annual inspection of the damaged sealing mechanism at olympus; 2) conduct pre-cleaning and manual cleaning on the tjf-q180v, as instructed in the tjf-q180v reprocessing manual, even when using the endoscopes automatic reprocessor ("aer"), which has instructions that may indicate that the user could fail to perform a few steps in the pre-cleaning and manual cleaning of the endoscopes; 3) the new reprocessing manual is providing instructions for using the new cleaning brush to remove impurities from the elevator recess area.
Action
Action code FA_148_03. Sending of letter- updating of instructions for use and reprocessing, new brush and new design- of 02/03/2016 to customers affected by email and mail //// submit the updated Anvisa registry new instructions for use and reprocessing, adding a new cleaning brush //// Sending all affected customers free disposable cleaning brushes //// Schedule service training for all affected customers on new cleaning procedures //// Sending second letter to schedule the replacement of the lift mechanism for new design. Code FA-148-03
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
Reinforced the need to adopt the following instructions: OBI version 1.5 and OBI 1.6: Navigate to the OBI application and select the "Cancel" button. The cancellation process can take anywhere from 5 to 30 seconds to complete. Restart the CBCT * acquisition process (See document CP-22609 in its entirety). OBI Version 1.4: Disable the CBCT field on the 4DITC workstation. Restart the OBI computer (s) and Reconstructor. Restart the OBI application. Enable the CBCT field on the 4DITC workstation. All versions of OBI: Contact your local Varian Medical Systems service department to report an incident of CBCT acquisition failure. #### UPDATED ON 08/24/2017, the company sent a completed action report of the field proving that a correction has been made as expected.
Reason
Varian has received numerous reports on the locking of the acquisition of the on-board imager® cone beam ct [cbct] that prevents the reconstruction of the image. a repeat of the scan is required. there are two possible symptoms: 1) the cbct application stops updating the display during acquisition. 2) an exception occurs during acquisition. although the cbct projections have been acquired, it will not be possible to generate the reconstructed cbct and the scan must be repeated. varian company describes that no administration failures or injuries were reported due to this problem.
Action
Action code CP-22609. Send security warning to all affected clients.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
Actions to be taken by the client / user: It was recommended to consider that: The implementation of the software correction is mandatory for the affected systems and will be installed by a Roche Diagnostica Brasil Representative. Until the software fix is implemented, it was recommended that the client / operator monitor the system for the missing tube error 140. If the described situation occurs, all components in contact with the spill must undergo an extra cleaning, as described in the operator's manual. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
Reason
Roche diagnostics gmbh, the legal manufacturer of the product involved in this notification, after a complaint reported abroad, identified the need to update and correct the software of the cobas p 512 pre-analytical system. such modification is necessary because of the incorrect insertion of (rtt), generating risk of contamination of the system and other samples, in addition to loss of material for analysis. so far, this problem has occurred in only three systems of about 400 systems installed in the world. in brazil, no similar complaint has been reported so far.
Action
Action code SBN_CPS_2016_01. Send letter elaborated on 02/26/2016 of communication to affected clients //// Implementation of software correction for the equipment. If you have any questions regarding this action call 0800-7720295
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
According to CMOS DRAKE, "The watchdog circuit already existing on the Cardioversor has the sole and exclusive purpose of resetting the equipment in case the equipment is locked for external reasons. It is not mandatory, as it does not influence stability, safety, does not affect performance and does not change the functional characteristics of the equipment. The mentioned technical intervention will allow the Watchdog circuit to work within a range closer to the limits calculated for the reset, guaranteeing better performance of the circuit in question. "##### UPDATE: On 02/22/2016 Certification of Good Manufacturing Practices of CMOS Drake of Nordeste Eireli - CNPJ: 03.620.716 / 0001-80, published by Resolution RE No. 4,482, of 11/14/2014, published in the DOU nº 222, of 11/17/2014 ( Section I, pages 43 and 44, and in Supplement to Section I, page 168), considering the non-compliance with the Good Manufacturing Practices requirements set forth in current legislation for the Health Products area. / 04/2016 was rejected the request Certification of Good Practices of Manufacture of Health Products of the Company DC Heart Defibrillators and Medical Systems Ltda. - CNPJ: 13.676.954 / 0001-60, through RESOLUTION - RE N ° 1,043, OF 20 OF APRIL 2016, published in DOU DE 04/25/201 6 ## UPDATE ON 07/4/2016: CANCELLATION BY THE CERTIFICATION ORGANIZATION OF THE CERTIFICATES FOR THE REFERRED PRODUCTS, AS FOLLOWS "II - Cancellation by other types of non-conformities not related to tests. Evidences of non-conformities and deviations from process encountered in the QMS during the maintenance process. " ## UPDATE: On 08/18/2016 Intertek issued the Certificates Numbers MED 0521 / C 0689.16 and MED 0521 / C 0688.16, for the Vivo Cardioversor products - Registration: 80058130015 and Cardioversor Life 400 Futura - Registration: 80058130008, respectively.
Reason
Replacing the d59 diode that is within a working range closer to the calculated limits for the reset in the event of an external fault causing the machine to be locked.
Action
The field action involving the Life 400 Plus Futura and Cardioversor Vivo Cardioversors is aimed at replacing a diode located at position D59 of the electronic circuit board CBI300.03 in order to improve the efficiency of the watchdog circuit (responsible for restarting the machine if there is any blocking by external events) a) Classification of risk CLASS III - Situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences; b) Classification of the field action - Correction in the field for correction of parts and pieces; c) Field action code - 001/2016; d) recommendations to users and patients - The watchdog circuit is not designed to provide user and patient safety, but to reset the device when possible external events cause it to crash (which rarely happens). The equipment can be used normally without any limitation as it does not influence the stability of the product and does not affect its performance. LETTER TO THE CUSTOMERS IN ANNEX. Code 001/2016
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
According to the company, the client "(...) can continue to use his anesthesia machine. If its practice involves the use of 21% O 2 in the fresh gas, any adjustment of the fresh gas flow rate will produce an inhaled bolus of anesthetic agent. The effect of the bolus on the concentrations of inhaled and expired agents is short-lived. Note the possible effects of elevated anesthetic agent concentration for short periods of time. In the event of the problem described above, the anesthesia device will automatically recover and return to the configured concentration of constant state anesthetic agent without any action of the user. Depending on the system configuration, one or both of these alarms can be activated if this safety problem occurs: • Clinical alarm "Fi XXX High" (XXX indicates the specific agent) • Alarm if respiratory gas monitoring is not present "
Reason
According to the company, "as of december 7, 2015, ge learned of a potential safety problem involving momentary autocorrection of the anesthetic agent bolus when using oxygen at 21% on all updated aisys cs2 and aisys appliances (version 10.X). aisys cs2 and aisys upgraded anesthesia machines can produce a momentary autocorrection of the increase in anesthetic agent, affecting inspiratory and expired concentrations for a short period of time, after one of the following configuration changes: • altering the fresh gas oxygen at 95% -25% for air only (oxygen at 21%). • any change in the total flow while using oxygen at 21% (air only). the occurrence of failure may generate momentary bolus production of anesthetic agent. the bolus will not occur with nitrous oxide as the carrier gas (balance) or when the oxygen concentration is set above 21% (air only). ".
Action
The company will perform field correction for software upgrade. LETTER TO THE CUSTOMERS IN ANNEX. IMF Code 34075
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
According to the company, the customer must "Identify SynchroMed II pumps manufactured prior to project changes through product identification number and expiration date. According to the following information: Product Identification Number for pumps manufactured before design changes: • Model 8637-20: PIN 863702007H • Model 8637-40: PIN 863704007H Any pump with an Expiration Date on or before May 14, 2017 was manufactured prior to design changes. Wait for the Medtronic Representative to contact you for equipment recovery. "
Reason
Medtronic has incorporated enhancements to the synchromed ii pump, which reduces the possibility of an internal short circuit and motor corrosion, resulting in less effective treatment. currently all synchromed ii pumps are already manufactured with these improvements. the statement is intended to inform customers that medtronic representatives will, through each customer's inventory review, retrieve any out-of-use synchromed ii pumps manufactured before design changes with the above improvements.
Action
The company will carry out field corrections. LETTER TO THE CUSTOMERS IN ANNEX. Code FA696.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data
Ortho's research identified that the results generated using plasma samples showed positive deviations compared to the use of serum samples for the same patient. Our data indicate that the samples expected to be below the measurement range (<2.39 mIU / mL (IU / L)) may potentially be reported at 7.72 mIU / mL (IU / L). Ortho recommends that you review previously reported Beta-hCG results of <9.00 mIU / mL (IU / L) for plasma samples processed using the affected batches. Talk to your Lab Medical Director about any questions you may have about previously reported hCG results to determine the appropriate course of action. The results of this or other diagnostic test should be used and interpreted only within the context of the general clinical picture.
Reason
Ortho clinical diagnostics (ortho) has confirmed that in performing tests using the batches listed above, vitros® systems generated results within the measurement range for samples known to have no measurable hcg. customers reported that their vitros® system generated results of up to approximately 7.40 miu / ml (iu / l) for patient samples that should be below the test measurement range (<2.39 miu / ml (iu / l )).
Action
The company will promote the collection of the product and subsequent destruction. Action Code: 16000022. According to the company, the customer shall: I. Immediately discontinue use and dispose of all remaining inventory of batches listed above VITROS® Reagent Calibrators and Kits for Total β-hCG II. The company will replace your remaining inventory or make a credit to your account, as indicated on the Receipt Confirmation form; II. Review previously reported results using affected batches of VITROS® Reagent Kits for Total β-hCG II. III. Contact your Laboratory Medical Director regarding any questions regarding previously reported results to determine the appropriate course of action. IV. Insert this notification into your VITROS® System or together with your documentation. LETTER TO THE CUSTOMER IN ANNEX.