Events

Recall of Kenex suspension arm with radiation shield and/or surgical lamp

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-2014-RN-00407-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00407-1
  • 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 recently become aware of an improper installation of the kenex suspension arm of a radiation shield. the suspension arm was not installed by ge healthcare per specified installation requirements. there is no deficiency associated with the kenex suspension arm. there has been one reported incident of a radiation shield falling from the ceiling causing a minor injury.
  • 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.

Device

Kenex suspension arm with radiation shield and/or surgical lamp

Manufacturer

GE Healthcare Australia Pty Ltd