Events

Recall of Brivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540 (all configurations)

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-01089-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01089-1
  • 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 recently become aware of a potential safety issue related to the manual film composer feature on some ct products. while following a specific workflow, there is potential to create a film image with one patient's images and another patient’s name in the footer. there is also another issue when within manual film composer, if a colour image is selected for printing, another patient’s black and white image appears in the preview screen and the colour image cannot be printed.
  • Action
    As a temporary work around, GE is asking customers to always review the patient images and patient name on footer in the Manual Film Composer feature to ensure that they match . GE is providing temporary work around instructions on how to print the colour image from the Manual Film Composer. GE Healthcare will undertake a software update on each affected system as a permanent solution.

Device

Brivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540 (all configurations)
  • Model / Serial
    Brivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540 (all configurations)ARTG Number: 93337
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd