Events

Safety Alert for surgical table system

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Maquet Gmbh & Co. Kg || Maquet Sas || Maquet (Suzhou) Co., Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1512-596
  • Event Number
    2014DM-0012045
  • Date
    2015-12-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=163
  • Notes / Alerts
    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 the extension can be removed from the table when it is subjected to a collision, if it is not positioned according to the instructions for use, leading to the occurrence of potentially adverse events on the patient.

Device

surgical table system
  • Model / Serial
    MAGNUS, concerning the extension device reference 1180.19X0
  • Product Description
    The surgical table system is used for the placement and positioning of patients for surgical treatment immediately before, during and after the operative phase. The surgical table system is accompanied by a set of accessories that allows it to be configured to adapt to the different requirements of a wide range of surgical treatments.
  • Manufacturer
    Maquet Gmbh & Co. Kg || Maquet Sas || Maquet (Suzhou) Co., Ltd

Manufacturer

Maquet Gmbh & Co. Kg || Maquet Sas || Maquet (Suzhou) Co., Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NIDFSINVIMA