Events

Recall of GE FlexiView 8800 Mobile C-Arm Mobile Imaging Systems

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by GE Medical Systems (India) Private 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
    13732
  • Event Initiated Date
    2012-10-31
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Reason
    The manufacturer advises that the system may lock-up during system usage; the system may stall during the boot cycle; when the image directory is accessed and thumbnail images are used to recall patient images, incorrect images may be displayed or there may be an inability to locate images on the system; failure of the system to display the international standard quantity, air kerma, to describe the radiation output.
  • Action
    Software to be upgraded

Device

GE FlexiView 8800 Mobile C-Arm Mobile Imaging Systems

Manufacturer

GE Medical Systems (India) Private Ltd