Events

Recall of PET Discovery 600 and PET Discovery 690, with software versions pet_mict_plus.44 and pet_velocity.53 (Nuclear medicine diagnostic system)

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-00014-1
  • Event Risk Class
    Class I
  • 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-00014-1
  • 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 due to scatter overcorrection associated with the list mode replay feature of the discovery 600 and discovery 690. a software issue exists when using list mode replay, such that subsequent reconstructions with that data could contribute to an image with scatter over-estimation and overcorrection. 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 and may lead to image misinterpretation and/or inaccurate treatment decisions.
  • Action
    To avoid this potential issue, GE Healthcare is advising customers to implement temporary workaround instructions through the customer letters. GE Healthcare will provide a software update for all affected systems to address the issue permanently.

Device

PET Discovery 600 and PET Discovery 690, with software versions pet_mict_plus.44 and pet_velocity...
  • Model / Serial
    PET Discovery 600 and PET Discovery 690, with software versions pet_mict_plus.44 and pet_velocity.53 (Nuclear medicine diagnostic system)ARTG Number: 156649
  • Product Classification
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd