Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The health agency of brazil has decided to suspend the use, importation, distribution and sale, following the findings made during the international inspection carried out in the facilities of the manufacturer kyungwon medical co., ltd, related to nonconformities of the manufacturing process, leading to their use being presented potential adverse events on users.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer informs that the client has reported problems since the month of the connectivity between the xponent 4.2 software and the medical device, which have been presented in a randomized manner, these problems are manifested with the error message "error getting device property" and subsequent blocking of the software, being necessary to restart the pc and analyzer to solve the inconvenience, leading to potentially delays in the processing of the samples and subsequent obtaining results.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer reports that he has detected during the washing of the device before the insertion or post-insertion of the purple tubes, leading to possible adverse events on the patients.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
Invima informs that through ivc's visit it was possible to prove that the referenced product was marketed and implemented without meeting the full requirements of the technical and legal provisions that regulate it, for which the product was withdrawn from the market in a preventive manner, as it is considered a fraudulent product.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer has determined that in the referenced devices there is a possible deviation of the measures according to the technical specifications, leading to the occurrence of possible adverse events on the patient or delays in the procedure.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer has reported the need to remove referenced devices from the market, preventing possible adverse events from occurring on patients.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer has detected that there is a possibility that the pivot pin assembly on the surface of the table may become loose when the table is articulated, which could lead to the occurrence of potentially adverse events on patients or users.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer who has identified a problem with excessive flexing of the tube by the user, especially at a sharp or abrupt angle, can cause the electrode wires to flow into its channel in the silicone wall, leading to potential adverse events occurring in patients.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer reports that it has detected the possibility of an alteration in the packaging causing a violation of the sterile barrier, leading to the occurrence of possible adverse events on patients.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer reports that he has detected problems with the aforementioned medical devices during the start phase, due to the presence of air in the dialyzer that could lead to the coagulation of the blood during the treatment, which can lead to the occurrence of potentially adverse events on the patient.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer states that it has detected that when using the option of overlapping tumor fraction in planning with vmat, the system includes a surrounding organ in the destination volume, resulting in an overdose of radiation, leading to potentially adverse events occurring on the patient.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer states that medical-referenced devices may present a loss of suction during treatment, in addition to the alteration in the incision mode of cataract, resulting in the same parameters for both eyes, leading to potentially adverse events occurring in patients.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer reports that it has detected the possibility that the superimposed text of the i / d and a / p values corresponding to the identification of laterality and position of the image, are shown inverted in the images of computerized tomography and magnetic resonance that are received in the image image software. , leading to confusions of medical personnel and potentially adverse events on patients when erroneous readings of the obtained images are made.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer informs that due to a defect in the manufacture of the batteries, the risk of thermal damage can be increased, leading to the potential occurrence of adverse events on patients or users.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
Stability problem of the calibrators that are included in the pigf kits, which causes loss in the signal level measured up to 20%.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer reports that it has detected the possibility that the patient support table may not move in the horizontal direction when the command is given to do so during computed tomography, due to a possible failure of the mechanical connection, the system can not automatically detect this error to abort it image or alert the user, leading to the occurrence of potential adverse events on the patient.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer reports that the formula of duplication time is defined incorrectly in the analysis of pulmonary nodules (lna), it can generate a wrong calculation of time of duplication leading to an incorrect diagnosis, which could lead to the occurrence of potential adverse events about the patients.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer reports that the self-transfer of information to remote devices (such as pacs), where there is the possibility of intermittent failure to send a series of images or information automatically, leading to potential delays in patient care.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer reports that the varian rpm unit is not assigned to the user profile after starting / closing session, the unit mapping function assigns the varian unit using all the credentials of the unit in the login service and then creates a script that maps with all the varian credentials in the user of the ct system, once the script is executed in the logon of thect system and the user recognizes the successfully mapped unit, the script deletes itself, in subsequent starts, the unit will not connect due that the varian credentials will no longer be available, if this situation occurs, the user will not be able to execute closed pulmonary scans, leading to the occurrence of potential adverse events on the patients.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer the manufacturer reports that the referenced devices present the following series of drawbacks: 1) cardiac mri - irregular appearance of the contrast in vessels.2) losing annotations on image in cct.3) artifact halo.4) unable to fit z locations in the pre-scan and ct scanner of 4d.5) wrong z annotations in the planned box for coronary / sagittal inspection (see aclient information chart) .6) unintentional change of acquisition time in the scanner rule.7) bolo tracker not it is activated as expected.8) system does not respond when paused.9) unplanned results during multiphase pulmonary series could cause a system collision.10) communication errors between the computer host and the gantry.11) artifact mill of wind with a zone width of 0.67mm. if these situations occur, they could lead to potential adverse events on patients or delays in care.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer the manufacturer reports that the referenced devices present the following series of drawbacks: 1) during the engraving operation in the software console of the mx16, the clipboard used to copy and paste images is not cleaned between patients. if the operator fails to copy the current patient's images before pasting them, the previous patient's images may be present on the new clipboard and copied to the current patient's recording.2) during scanning for bolus tracking, if the auto voice tracking function is enabled scanning by scanner will be aborted unexpectedly and the scanner after scanning will need to be manually initiated.3) if the scanner protocol with the sas (spiral autostart) function is selected to plan is scanned, the option sas could not be displayed in the scanner. contrast button in the protocol parameters area of the sas option scanner is not enabled as it is pre-configured in the protocol. this inconvenience only occurs in the first helical scanner after the system has been restarted by applying the sas function (this problem only occurs in the next scanner if a helical scanner has been executed after the system restart). if these situations occur, they could lead to potential events adverse to patients or delays in care.