Events

Recall of Discovery NM/CT 670, Optima NM/CT 640, Discovery NM630 and Brivo NM615 (all configurations) (Nuclear Medicine 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-2013-RN-01062-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01062-1
  • 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
    Contact between the detector and the patient's elbow may occur during spect protocols using 45 degree angular steps in scenarios when a patient's arms are positioned above the head and when dedicated safety armbands are not utilised.
  • Action
    GE Healthcare is advising users to ensure the patient and the patient's extremities are not protruding beyond the table limits. GE is advising that if the patient's arms need to be extended above their head, to use the provided armbands. A software update will be provided by GE by February 2014.

Device

Discovery NM/CT 670, Optima NM/CT 640, Discovery NM630 and Brivo NM615 (all configurations) (Nucl...
  • Model / Serial
    Discovery NM/CT 670, Optima NM/CT 640, Discovery NM630 and Brivo NM615 (all configurations) (Nuclear Medicine System)ARTG Number: 200439
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd