Events

Safety Alert for STERRAD NX

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Cilag Gmbh International || Johnson & Johnson Medical Limited. || Advanced Sterilization Products.

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
    I1702-30
  • Event Number
    2007DM-0000979
  • Date
    2017-02-06
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=104
  • 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 has detected that after an external power interruption, the door lock system can be deactivated for a period of 20 seconds while the system is restarted, allowing the possibility of opening it, when the user must open the door of the device's camera only if requested by the user graphic interface (gui) in accordance with the user's guide, leading to the occurrence of potentially adverse events on users.

Device

STERRAD NX

Manufacturer

Cilag Gmbh International || Johnson & Johnson Medical Limited. || Advanced Sterilization Products