Events

Recall of GE Healthcare LightSpeed CT scanners & Discovery PET CT scanners with replacement MDAS 16 5V Power Supply (part number 2334455)

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-2015-RN-00699-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00699-1
  • 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 become aware that the service procedure used to replace a power supply on the rotating side of the gantry specified the incorrect torque for the mounting hardware. because of this error, the three mounting bolts securing the power supply could have been over-torqued when the component was replaced on your system. plastic deformation of the bolts from over-torqueing could worsen over time and eventually fail. however, all 3 bolts holding the power supply would have to fail for the part to fall. in the unlikely event that the component becomes loose on the ct gantry during operation, it could result in serious bodily injury if the component were to be expelled. there have been no incidents or injuries reported as a result of this procedure error.
  • Action
    GE Healthcare will correct all affected products at no cost to users. This action has been closed-out on 15/08/2016.

Device

GE Healthcare LightSpeed CT scanners & Discovery PET CT scanners with replacement MDAS 16 5V Powe...
  • Model / Serial
    GE Healthcare LightSpeed CT scanners & Discovery PET CT scanners with replacement MDAS 16 5V Power Supply (part number 2334455) Affected Product: The following CT Scanners, manufactured from 2003 – 2006:· LightSpeed Ultra (8-slice MDAS)· LightSpeed Plus (4-slice MDAS)· LightSpeed QX/i (4-slice MDAS)· LightSpeed 16 (MDAS Only)The following PET CT Scanners, manufactured from 2003 – 2005:· Discovery ST· Discovery LS ARTG Numbers: 96044 and 156649
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd