Events

Recall of Infinia, Infinia Hawkeye, Millenium VG, VG Hawkeye and VariCam Nuclear Medicine Systems, All configurations

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-00143-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00143-1
  • 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 related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. a potential life-threatening hazardous situation may occur if there is unintended radial detector motion leading to a patient contact. this failure mode has been observed on a single system for a whole body scan, in which detector moved to the home position and then slowly started drifting inward toward the patient. this generated both a visual and audio alert condition on both the console and the gantry.
  • Action
    GE Healthcare is providing safety instructions to prevent any patient injuries if this failure mode occurs in the field. A GE Healthcare Service representative will perform the required service action (that includes a software update) on each affected system.

Device

Infinia, Infinia Hawkeye, Millenium VG, VG Hawkeye and VariCam Nuclear Medicine Systems, All conf...

Manufacturer

GE Healthcare Australia Pty Ltd