Events

Safety Alert for medical washer

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Getinge Sterilization Ab || Getinge Disinfection Ab || Getinge Sourcing Llc.

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
    I1506-254
  • Event Number
    2014DM-0011890
  • Date
    2015-06-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=178
  • 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 affirms that previously identified medical devices can allow an authenticated remote access through its network interface admitting access to the parameters and internal programming, where the modification would compromise the functioning of the same, leading to the presentation of possible adverse events on the patients due to potential infections. crossed.

Device

medical washer

Manufacturer

Getinge Sterilization Ab || Getinge Disinfection Ab || Getinge Sourcing Llc
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NIDFSINVIMA