Events

Recall of Proteus XR/a X-ray imaging systems manufactured with wall stand model number 2260354.

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-00116-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-02-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00116-1
  • 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 a potential safety issue involving the breakage of the steel cable which support the bucky device in certain wall stands of proteus xr/a x-ray imaging systems. a fall of a bucky while the system is in use could result in an injury to a patient or operator. there were no injuries reported as a result of this issue.
  • Action
    GE Healthcare will inspect, and repair as necessary, all affected systems. A GE Healthcare service representative will contact customers to arrange for this correction. Additionally, the Service Procedure which defines the service interval for periodic cable maintenance and replacement is being updated to require a cable replacement every 15 years, and specify annual inspections of the counterweight guide rail bolt paint marking to confirm tightness of the bolt. This is to ensure the ongoing safe operation of this device. This action has been closed-out on 16/02/2016.

Device

Proteus XR/a X-ray imaging systems manufactured with wall stand model number 2260354.

Manufacturer

GE Healthcare Australia Pty Ltd