Events

Recall of PET Discovery 610 and Discovery 710 with software version pet_coreload.44 and pet_mfk.44

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-01265-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01265-1
  • 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
    A software issue exists when using list mode replay feature, such that subsequent reconstructions with that data could contribute to an image with scatter over-estimation and overcorrection artifacts which may be presented as 'black background' and creates an apparent perfusion defect. reconstructed images with this issue will have many fewer counts than the acquired scan data and a high scatter fraction. this issue may affect studies that use list mode replay and are reconstructed after subsequent acquisitions. this issue may lead to image misinterpretation and/or inaccurate treatment decisions.
  • Action
    GE Healthcare is providing users with work around instructions to follow as an interim measure. A software upgrade will be performed as a permanent fix.

Device

PET Discovery 610 and Discovery 710 with software version pet_coreload.44 and pet_mfk.44

Manufacturer

GE Healthcare Australia Pty Ltd