Events

Recall of GE PET Discovery 600 and Discovery 690 Nuclear Medicine System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by GE Medical Systems LLC.

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
    16008
  • Event Initiated Date
    2014-01-09
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Reason
    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., this issue may lead to image misinterpretation and/or inaccurate treatment decisions.
  • Action
    Software to be upgraded

Device

GE PET Discovery 600 and Discovery 690 Nuclear Medicine System
  • Model / Serial
    Model: 600 & 690, Affected: , Software version: Software versions pet_mict_plus.44 and pet_velocity.53
  • Manufacturer
    GE Medical Systems LLC

Manufacturer

GE Medical Systems LLC