Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
Beckman coulter has determined that some ultrasonic transducer kits were potentially assembled with incorrect mounting screws. one of these transducers may have been installed on the system during a recent instrument repair. over time the screws can become loose if a combination of correct and incorrect screws are used and possibly cause incorrect probe wash, splashing in the reaction vessels (rv), incorrect particle suspension in the reagent pack, or incorrect rv mix due to alignment of the probe to wash tower/rv leading to assay imprecision. this may cause erraneous but believable results and/or delay of results due to transducer alignment error.
Action
Users are advised to review historical QC data and System Check results since the transducer was installed for any indication of a potential problem and determine whether a review of patient test results is warranted. A service representative will be contacting users to schedule a service visit to confirm that their transducer is properly installed.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
When using the 9l4 transducer in combination with virtual touch quantification (vtq), the displayed mechanical index (ie, the ml value which reflects the risk of mechanical cavitation that could cause tissue damage) may be outside the stated tolerance of +/=15%. this occurs only between the depths of 2.5cm and 3.4cm. to date, no patient injury has been reported.
Action
Users are advised that the MI values should be interpreted as relative information and used only to assist the operators in implementing the ALARA (As Low As Reasonably Achievable) principle during patient examinations. For systems with software version VC25, Siemens is updating the Instructions for Use regarding the tolerance of the Mechanical Index (MI) displayed values. For systems with software version VC30A, Siemens is updating the software. This action has been closed-out on 18/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
The mobilediagnost wdr executes an unintended exposure under the following specific error conditions:- the hand switch is erroneously stuck in pressed position, while the system is switched off, - the system is powered up with the hand switch in that erroneous condition, - the user logs in, selects a patient for examination, gets a green ready light in, - the examination context, if the tube arm is then moved out of the zero position, the system is doing an exposure.The hazard associated to this defect is one single unintended exposure with the parameters configured previously by the user in the last examination. no continuous radiation is emitted in any case.
Action
Philips plans to update the software Philips Service Engineer will contact customers as soon as the Field Action Kit is ready to be implemented. The system can be used according to the Instruction for Use without restrictions. This action has been closed-out on 10/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
During use, the bolt in the connection between the spreader bar and the lifting arm jig is subjected to mechanical forces, which may lead to breakage. this is due to the design of the connection between spreader bar and lifting arm jig, which in long term use can cause metal fatigue in this part and the formation of micro-cracks in the thread of the bolt. this issue is only related to tenor devices without scales.
Action
ArjoHuntleigh will arrange for the replacement of the old spreader bar with a new spreader with scales. This action has been closed-out on 12/02/2016.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
Baxter is adding a contraindication statement to address iodine allergy for baxter’s peritoneal dialysis products which contain iodine (i.E. povidone iodine) or for which iodine use is recommended.
Action
Baxter is updating the instructions for use to include additional contraindications for iodine sensitive patients. End users are being notified of the new contraindications.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
Investigations have shown that the neonatal flow sensor insert (8410179) can leak after connecting the plug. this was caused by a tool within the neonatal flowsensor insert production process.
Action
Drager requested their customers to review their stock and return once replacement stock was available.
This action was undertaken prior to notifying the Therapeutic Goods Administration.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
This action is undertaken to inform users of an update to the instructions for use (ifu) for the thermablate endometrial ablation system (eas). the ifu updates are in the following sections:1) directions for use / treatment - includes an additional precautionary step in the sequence of procedures just prior to inserting the thermablate catheter into the uterus to initiate treatment. the sequence now includes a requirement for a second sounding of the uterus just after dilation and before performing hysteroscopic examination of the uterus to confirm that perforation of the uterus or the creation of a false passage has not occurred during the dilation and soundings.2) contraindications – the current contraindication i.E., “a patient with lower segment c section scar that has a linear scar thickness of less than 1cm” is being amended to “a patient that has had three or more, lower segment c sections and where the linear scar thickness in those patients is less than 8mm”.
Action
Customers are provided with the updated IFU along with the customer letter. This action has been closed-out on 11/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
In the assay details screen, certain configuration parameters selected during configuration of reference ranges for assays may cause the reference ranges to not hold results as expected. this may cause the release of results to the laboratory information system (lis) that should have been held for manual review.
Action
Siemens is notifying hospitals and laboratories of specific limitations with the use of sample reports in the syngo Result Manager that have not been previously communicated in the Operator's Guide.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
There is an increased risk that the vibration alarm will not work, as a result of a changed component. this fault will only be detected at pump start up, when it will display an ‘e-7’ error message and give an audible signal, but will fail to start. safety features such as the continuing audio signal as well as a visual notification will enable the user to detect the issue immediately and thus prevent from using an incorrectly functioning device.Br /br /the tga has published a web statement regarding this issue. for more information, please refer the following link: http://www.Tga.Gov.Au/safety/alerts-device-accu-chek-insulin-pump-140606.Htm.
Action
Roche is advising Accu-Chek Spirit Combo users of the potential for frequent E7 errors and reinforcing the instructions on how to clear the error. If the E7 error occurs repeatedly users are requested to contact Roche for a replacement device. This action has been closed-out on 10/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
The problem can occur when the field of view of the clinical stations is below (more towards the feet) the light visor position. in such a situation an error is made in calculating the position information. this causes incorrect positioning of cross-reference lines on fused sagittal images.The cross reference lines of transversal images are displayed in an incorrect position on a fused image which has been generated through mobiview post processing. the cross reference lines are correctly displayed on the unfused stations.
Action
Philips is advising end users to not perform planning or review planning of transversal images on fused sagittal images which were generated through MobiView post-processing. Philips field service engineers will disable the MobiView post processing software until a software update has been developed and distributed. This action has been closed-out on 12/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
The monitored minute volumes (vmin) are reported at ten times actual value on the bedside monitor. the source of this error is associated with a change in the flexport communication protocol between versions 1.1 and 1.2. all alarms and setting levels on the bedside monitor continue to perform properly and are unaffected by this error. the reported x10 volumes would be an obvious error to the clinician.
Action
Medtel Australia is notifying their customers of the issue and advising that the ventilator performance is not affected. A software update will be implemented to correct the issue. This action has been closed-out on 12/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
Certain aaa backup battery packs may have been wired incorrectly. this wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up.
Action
Philips is providing replacement battery packs for all units from the affected lots. This action has been closed-out on 11/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
Due to a higher frequency of reported adverse events related to cardiac perforations and atrio-esophageal fistula johnson & johnson medical is updating the ifu to include the following information:- verify that the catheter selection knob on the compatible rf generator is on the “tcool sf” or thermocool sf similar option and ensure that the maximum temperature is set at 40°c- do not rely on electrode temperature rise to determine if tissue heating is occurring during rf energy delivery as bench and animal studies showed no significant electrode temperature rise during rf ablation.J & j is also providing information to reinforce procedural steps and precautions set out in the ifu.
Action
J & J is notifying their customers of additional information included in the IFU:
- Verify that the CATHETER SELECTION KNOB on the compatible RF generator is on the “Tcool SF” or Thermocool SF similar option and ensure that the maximum temperature is set at 40°C
- Do not rely on electrode temperature rise to determine if tissue heating is occurring during RF energy delivery as bench and animal studies showed no significant electrode temperature rise during RF ablation.
J & J is also providing information to reinforce procedural steps and precautions set out in the IFU.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
Certain silicone tecnis iols may be labelled with the incorrect diopter power. use of a mislabelled iol could lead to potential unexpected postoperative refractive error and may result in a secondary surgical intervention to correct.
Action
Abbott Medical Optical (AMO) is requesting their customers to remove affected devices from their inventory. Affected devices are to be returned to AMO and replacements provided.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
Roche diagnostics has identified that a small number of people with diabetes using the accu-chek mobile device have experienced falsely elevated blood glucose readings when using the system as a result of not following the described and labelled handling instructions. such improper handling can include, for example, unclean hands contaminated with glucose-containing substances, pressing the finger too hard and too long on the test field or smearing the blood while performing a test. roche has decided to enhance its training and handling instructions for the accu-chek mobile system – increasing their visibility in the meter kit to ensure people with diabetes’ understanding of how to appropriately use the system. this will enable the users to obtain safe and reliable blood glucose (bg) readings at all times.Br /br /the tga has published a web statement regarding this issue. for more information, pleaser refer to: http://www.Tga.Gov.Au/safety/alerts-device-accu-chek-glucose-meter-140606.Htm.
Action
Consumers are advised to continue to use their Accu-Chek Mobile device safely and reliably by carefully following the instructions that are described in the User Manual and which can also be found in a new instructions leaflet available at www.accu-chek.com.au. Specifically:
· Wash your hands with warm water and soap. Dry your hands thoroughly before obtaining a blood sample.
· Form a proper blood drop and apply it to the centre of the test field.
· Immediately apply the blood gently to the test field after you have created the blood drop.
· Do not press against the test field on the tape.
· Touch the test area gently and your finger should be removed from the test field when the beep tone sounds and/or “test in progress” is displayed.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
During manufacture, the notching completed on one specific machine may have been started too close to the end of the shank. in some products (approximately 1/1000), there may be missing notches, partial notches or no notches at all. the listed cutting accessories are manufactured with notches at the proximal end of the bur. the notch is a feature on the bur that is used to retain and control the exposure of the bur within the drill/attachment. the correct number of notches varies from 2 to 5, based on the specific product number.
Action
Stryker is requesting their customers to quarantine all affected stock and advising that they will be contacted to organize for the return of the product.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
Ge healthcare has recently become aware of a potential safety issue due to possible sound loss associated with the carescape monitor b650. when an external display is connected to the carescape monitor b650 using a usb extender cable with an active usb hub, the system may experience a sound loss including alarm sounds from the patient monitor. this may occur if the external display is powered off and on during normal operation of the monitor.
Action
GE is advising their customers that this issue can be avoided by not switching the external display off and then switching it back on during normal monitor use and by not using a USB extender cable with active hub. If the sound loss occurs during normal operation of the monitor, users can enable the sounds back on by restarting the monitor. A software patch will be provided to correct this issue permanently.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
Bd has determined that the crystal inoculum fluid within the bbl crystal enteric/nonfermentor (e/nf) identification kits from the referenced lots are labelled with incorrect expiration dates. the crystal inoculum fluid bottles expire prior to the date that was printed on the kit carton. the expiration date printed on the individual crystal inoculum fluid bottles is correct.
Action
BD is requesting their customers to discard the outer boxes that are labelled with the incorrect expiration date.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
A complaint was received for a volume discrepancy between the pad print (500cc) and laser engraved marking and all other product labelling (550cc) on a mentor gel sizer manufactured at mentor leiden. during the bounding investigation, a second lot was identified as having a style discrepancy between pad print (moderate profile, mp) and all other product labelling (moderate plus, m+). misjudging the size or style of an implant can result in asymmetric outcome, which may need additional surgery.
Action
Johnson & Johnson Medical (JJM) is requesting their customers to quarantine the affected stock immediately. Arrangements to return the product can be made by contacting the JJM customer service.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
Siemens healthcare diagnostics has received several reports from customers of one or more electrolyte parameters (e.G., na+, ca++, k+, cl-) reporting a “-----?” error code when aqc, qc, or cvm is run on the rapidpoint 500 blood gas analyzer. when exhibited, the issue is usually seen during level 1 qc /aqc, level 1 cvm, and sometimes level 2 cvm testing. this issue has also been observed on a small number of patient samples.
Action
Customers are advised that the following steps can be taken to mitigate the issue:
- Install a RAPIDPoint 500 Measurement Cartridge
or
- Install a 405 Measurement Cartridge. Customers will need to arrange to get the lactate results from other instruments in their central laboratory since the Lactate parameter is not available on the RAPIDPoint 405 cartridge
or
- Use an alternative system to obtain the electrolyte values.
Since this issue is not related to the AQC cartridge, installing a new AQC cartridge will not solve the problem.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
The bed rails do not comply with recent changes to iec 60601-2-38:1996 with regard to potential patient entrapment and side rail latches/ locks requirements.
Action
Better Living care is requesting their customers and end users to quarantine all affected units. Better Living Care will arrange for the recovery and replacement of the devices.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
The label on the head text does not match the multilingual text ie, the number of holes is not correctly indicated in the multilingual text in the labelling for one or more of the languages.
Action
Customers are advised to isolate the affected units and return it to Synthes Australia.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
The manufacturer, kerr corporation has received complaints that the amalgam may set faster than specified in the directions for use. this set time discrepancy may cause the product to set before there is an opportunity to place it in the preparation or to complete the carving process. there is a low risk associated with the use of this product in that there would be a possible need to remove the set amalgam from the preparation and repeat the procedure.
Action
Customers are advised to immediately return any of the affected stock to Kerr Australia for replacement with unaffected stock.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
The manufacturer, vascular technology, has identified a potential risk with the packaging for the vti bayonet doppler probe. a probe had penetrated the sterile barrier, possibly rendering the device unsterile. this represents a potential safety hazard, which could lead to infection.
Action
Customers are asked to determine if any unused stock exists at their site. Life Healthcare representative will collect any unused stock.