Events

Safety Alert for Universal Operating Tables

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Schaerer Medical Ag.

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
    I1610-446
  • Event Number
    2015DM-0013017
  • Date
    2016-10-26
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=116
  • 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 informs users of the referenced equipment that oil leaks may occur, their use in surgical environments increases the possibility of adverse events occurring to patients or users.

Device

Universal Operating Tables
  • Model / Serial
    AXIS 400 and AXIS 800
  • Product Description
    The SCHAERER MEDICAL AG universal operating tables stand out especially in the mobile operations processes, thanks to their extraordinary structure that provides great stability without loss of flexibility. The SCHAERER MEDICAL AG operating tables facilitate in this way that the interventions are carried out without problems, saving time.
  • Manufacturer
    Schaerer Medical Ag

Manufacturer

Schaerer Medical Ag