Events

Recall of Ventri and Discovery NM 530c (Full body computed tomography (CT) 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-00075-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-01-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00075-1
  • 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
    During a patient unload following a scan the patient's fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically.
  • Action
    Users are being advised to exercise special care before and during patient unload: 1- Strictly adhere to the following operator's instructions: "Verify that patient limbs do not protrude from the table pallet. Using the hand held controller, move the table out and then down. 2- Please ensure that the patient is observed at all times per the operators instructions. GE Healthcare will install a correction to all systems to mitigate the risk.

Device

Ventri and Discovery NM 530c (Full body computed tomography (CT) system)

Manufacturer

GE Healthcare Australia Pty Ltd