Events

Recall of FlexiView 8800 Mobile C-Arms (Mobile, general-purpose, diagnostic, fluoroscopic x-ray 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-2012-RN-01112-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01112-1
  • 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 surgery has finalised the corrections to remedy the issues communicated to the customers in 2006 and 2007 (tga recall reference #rn-2007-0077) . specifically, these corrections will address issues involving system lock-ups,incorrect image display, system stalls during the boot cycle, and failure of the system to display the air kerma and cumulative air kerma.
  • Action
    GE Healthcare is providing work around instructions to mitigate the risk and will be implementing a software update to permanently correct the issue.

Device

FlexiView 8800 Mobile C-Arms (Mobile, general-purpose, diagnostic, fluoroscopic x-ray system)
  • Model / Serial
    FlexiView 8800 Mobile C-Arms (Mobile, general-purpose, diagnostic, fluoroscopic x-ray system) ARTG Number: 92396
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd