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.
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 the device can produce low false readings of blood glucose in patients receiving ceftriaxone therapy, leading to the potential occurrence of 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 it has detected that the referenced kits lacking the coding chip can not be used subsequently, leading to possible delays in the analysis of patient samples.
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 the referenced device may have a 30fr sheath in place of the 24frappropriate sheath, this situation could be detected by the surgical staff and would result in prolongation of the intervention time while the device is changed accordingly, leading to the potentially increase the risk of presenting 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 informs that it has detected a case of falsification of its product in the city of villavicencio, marketed in plastic drippers labeled "napid fluor / whiter teeth, chewing gum flavor" and using the manufacturer's data and the sanitary registry of the original product, in addition the manufacturer he affirms that the product in mention is of dental use.
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 that the referenced medical device may have a package that does not correspond to the indicated size, leading to potential adverse events on the patients or delays in the procedure times.
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 that the referenced medical device may contain two stilettos with a coaxial trocar tip or two blunt-tipped stylets, instead of one of each, leading to potentially adverse events on the patients oprugating the surgical time.
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 a defect in the software in the referenced system due to failures in the calibration of the testpak and the status of the quality control (qc), which could lead to potential delays in the processing of the samples.
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 an end device.
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 identified that the referenced cables can be separated from the connector at the proximal end, leading to the presence 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.
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 identified a problem with the software that prevents the doctor from accessing the data of the device located in the carelink network, the transmission appears successfully for the patients, while in reality the transmitted data (carealerts) are not visible for the establishment of health, only monitors related to the implantable cardioverter defibrillator (icd) or the cardiac re-synchronization defibrillator (crt-d), which received software updates are unaffected, leading to potential adverse events being presented to 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 identified that the illustrations of the electrodesreferenced show an incorrect location of the electrodes for a baby, the art printed on the product is incorrect (shows the placement of the pink electrode on the back of the baby), on the other hand the illustration on the outer packaging if is correct (showing the placement of the pink electrode on the baby's chest), this situation could lead to potential serious 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.
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.
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 affirms that if additional scans are necessary prior to completing the current reconstruction, noting the planned images of the current reconstruction are shown to the user, even though the information is not separated, the gross information can be reconstructed off-line showing all the reconstructions requested, however, users may be unaware that the raw information is still available for offline reconstruction, leading to new scans and 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 in the referenced equipment, during the performance of high-resolution head scans, the reconstructed images may have a reduced image quality, which manifests as lack of image ununiformity, displacement of the tcmayor number to 5 hounsfield units, reduction in differentiation between gray / white matter, if these situations occur, could lead to the occurrence of potential 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 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.
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 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 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.