Events

Recall of Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine systems, Helix nuclear medicine systems, Brivo NM615, Discovery NM630, Optima NM/CT640, Discovery NM/CT670All manufacturing dates

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-2013-RN-00695-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00695-1
  • 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
    On wednesday, june 5, 2013, ge healthcare became aware of an incident at a va medical centre facility in the united states. according to information available, a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 due to a portion of the system falling onto the patient during the scan. ge healthcare has since determined that bolts securing the camera to the gantry were loose, thereby stressing the support mechanism and resulting in the incident.
  • Action
    GE recommends that users cease use of their Nuclear Medicine system until GE Healthcare can complete an inspection the affected systems. If an issue with the support mechanism fasteners is found on the affected systems, the GE Field Engineer will coordinate the replacement of impacted parts in the Gantry and ensure that the systems are operating safely. For more details, please see http://www.tga.gov.au/safety/alerts-device-nuclear-medicine-imaging-system-130709.htm .

Device

Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine systems, Helix nuclear medic...
  • Model / Serial
    Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine systems, Helix nuclear medicine systems, Brivo NM615, Discovery NM630, Optima NM/CT640, Discovery NM/CT670All manufacturing datesARTG Number: 200439
  • Product Classification
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd