Events

Recall of Infinia, VG, VG Hawkeye and Helix nuclear medical systemsAll Infinia nuclear medicine systems, manufactured from 2003-2013VG and VG Hawkeye nuclear medicine systems, manufactured from 1996-2003 Helix nuclear medicine systems, manufactured from 1992-1996 (by Elscint Ltd)

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-00629-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-06-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00629-1
  • 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 (hc) has recently became aware of an incident in the united states, a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 where the equipment fell onto the patient during the scan. gehc was permitted access to the equipment on 17 june 2013 and investigation is ongoing. as a result, gehc has not been able to determine the root cause of this incident.
  • Action
    GE Healthcare recommends that qualified service personnel maintain the equipment and that Preventative Maintenance procedures are executed according to the schedule provided in customer documentation. Customers are asked to review safety chapter sections with appropriate personnel to ensure proper operation of the equipment. GE Healthcare is working in conjunction with the TGA for a complete investigation into the incident and will undertake any further action if required.

Device

Infinia, VG, VG Hawkeye and Helix nuclear medical systemsAll Infinia nuclear medicine systems, ma...
  • Model / Serial
    Infinia, VG, VG Hawkeye and Helix nuclear medical systemsAll Infinia nuclear medicine systems, manufactured from 2003-2013VG and VG Hawkeye nuclear medicine systems, manufactured from 1996-2003Helix nuclear medicine systems, manufactured from 1992-1996 (by Elscint Ltd)Multiple products affectedARTG number: 200439
  • Product Classification
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd