Events

Recall of Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems

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-2016-RN-00001-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00001-2
  • 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 a potential safety issue related to the operation of the safety latch holding mechanism for the horizontal arm of the x-ray system. this safety latch mechanism serves as a backup in the unlikely event the primary safety cable breaks. in order to encounter the hazardous situation where the x-ray tube horizontal arm falls, it would require the following condition to occur simultaneously which is highly unlikely:1) the counter weight cable system (steel cable or pulley/idler) breaks.2) the safety mechanism does not engage and hold the tube–arm there have been no incidents or injuries reported as a result of this internally found issue.
  • Action
    GE Healthcare will correct all affected products. In the interim, users are advised to continue to use the system with caution. This action has been closed-out on 27/01/2017.

Device

Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems
  • Model / Serial
    Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systemsAll serial numbersARTG Number: 201698
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd