Events

Recall of Kenex ceiling-suspended radiation shields and surgical lamps

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00208-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-03-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00208-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Ge healthcare has become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. the pendent system was not installed per specified installation requirements. there has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.This action is an update of the product correction - rc-2014-rn-00407-1.
  • Action
    GE Healthcare is inspecting all affected systems to verify that the Kenex suspension radiation shields and surgical lamps are properly installed. A GE representative will contact customers to arrange for the inspection. Any affected systems will be corrected. This actio has been closed-out on 03/08/2016.

Device

Kenex ceiling-suspended radiation shields and surgical lamps

Manufacturer

GE Healthcare Australia Pty Ltd