Events

Safety Alert for Discovery 670, Optima 640, Discovery NM630 and Brivo NM615

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by GE Healthcare.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-10-16
  • Event Date Posted
    2013-10-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131016g.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: ge healthcare discovery 670, optima 640, discovery nm630 and brivo nm615 the therapeutic goods administration (tga), australia issued a medical device safety alert concerning discovery 670, optima 640, discovery nm630 and brivo nm615 (all configurations), manufactured by ge healthcare. contact between the detector and the patient's elbow may occur during single-photon emission computed tomography 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. ge healthcare advises users to ensure the patient and the patient's extremities are not protruding beyond the table limits. if the patient's arms need to be extended above their head, users are advised to use the armbands provided. a software update will be provided by the manufacturer. for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01062-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 october 2013.

Device

Discovery 670, Optima 640, Discovery NM630 and Brivo NM615
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: GE Healthcare Discovery 670, Optima 640, Discovery NM630 and Brivo NM615
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare