Events

Recall of OEC Elite systemsDistributed between 27 October 2016 and 28 March 2017

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-2017-RN-00643-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00643-1
  • 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 surgery recently identified that product use labels on certain oec elite systems were missing or applied in the incorrect location on the device. the missing labels have the potential to result in users overlooking safe operating practices and exposing themselves or others to potential hazards that may lead to significant harm. to date, there have been no injuries reported because of this issue.
  • Action
    Users are advised they may continue to use the OEC Elite system and to consult the Operator Manual regarding safe use of the system and precautions to be taken: - before initial use of the device - when transporting or moving the system - when connecting, or disconnecting external equipment/accessories - when locking, and unlocking brakes using the brake handle or pedal - when checking/contacting electrical connectors GE Healthcare will contact users to arrange for product correction.

Device

OEC Elite systemsDistributed between 27 October 2016 and 28 March 2017

Manufacturer

GE Healthcare Australia Pty Ltd