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 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
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 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
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 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 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 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.
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.
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.
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 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 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
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 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.
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.
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
It has been detected that in the labeling made in the factory, there is an error in the address of the importer printed on the packaging of the product, which can lead to the presence of potentially confusions in the opaque users and in contravention of the marketing requirements established normatively.
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 occlusion alarm is not activated as expected due to a software anomaly, possibly causing dehydration or hypoglycaemia, leading to potentially adverse events 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 a risk in terms of compliance with the sterilization, which could lead to 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 importer has detected quality failures of the referenced device, since at the moment of joining the needle with the syringe this fracture, including this condition has been evidenced before use, leading to possible delays in the procedures and adverse incidents with 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 it has detected the possibility of a software error that may alter the result obtained by the analyzer for the calculation of hemoglobin, 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
Voluntary withdrawal of the importer due to the impossibility of demodification of the insert.