Events

Recall of Revolution CT (diagnostic x-ray system)

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-00640-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00640-1
  • 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 a potential safety issue in the revolution ct patient table that can result in unintended motion in cases involving large patients. the revolution ct cradle can descend on its own after activation by the user. this can put the patient at risk for harm. the harm can involve the impinging or crushing of a hand if caught between the cradle and ct inner gantry bore. no injuries have been reported to date related to this issue.
  • Action
    GE Healthcare is advising users to continue to use the Revolution CT system, and ensure the warnings regarding Patient Positioning in the IFU are followed. GE will be correcting all affected systems. This action has been closed-out on 20/02/2017.

Device

Revolution CT (diagnostic x-ray system)

Manufacturer

GE Healthcare Australia Pty Ltd