Events

Recall of Precision RXI X-ray Imaging Systems equipped with LCD Video Monitor LCD Video Monitor

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-00016-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-01-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00016-1
  • 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 overhead lcd video monitor suspension. there is a potential for the locking nut to loosen out of the lcd video monitor suspension yoke. this will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and a screw in the absence of the locking-nut. to date, no injury has been reported due to this.
  • Action
    GE Healthcare is advising users that if inappropriate performance or excessive movement of the monitor is observed to immediately contact GE Healthcare. GE Healthcare is correcting all affected systems.

Device

Precision RXI X-ray Imaging Systems equipped with LCD Video Monitor LCD Video Monitor
  • Model / Serial
    Precision RXI X-ray Imaging Systems equipped with LCD Video Monitor LCD Video Monitor Model Number: 2385123-2 LCD Video Monitor Serial Number: 00000001386MC2ARTG Number: 99423
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd