Events

Recall of Proteus XR/a 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-2014-RN-01300-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01300-1
  • 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
    It was reported that both the steel cables in a proteus system wall stand failed and the bucky cabinet (68kg) fell to the floor. the unit was not in use, no patient or operator injury was reported. the proteus wall stand assembly associated with this event was identified as model 600-0301. the steel cable used with this wall stand is 603-3220. an investigation concluded that the root cause was fatigue of the braided rope.
  • Action
    1. GE Healthcare will correct all affected systems by replacing the steel cables at no cost. A GE Healthcare service representative will contact customers to arrange for this correction. 2. To prevent occurrence of these issues in the future, the Service Procedures including the service interval for periodic cable maintenance and replacement is also being updated. The updated Service Procedure (2273022-100 Rev 31) will be available by 15th Jan 2015 at a website link that is to be provided in the Customer Letter. This ation has been closed-out on 11/08/2016.

Device

Proteus XR/a X-ray Imaging Systems

Manufacturer

GE Healthcare Australia Pty Ltd