Events

Recall of INNOVA 2121IQ (Cardiovascular X-ray imaging 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-2014-RN-00210-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-03-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00210-1
  • 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
    The innova system may not boot up properly after a power-on or after a system reset. additionally it may shut down unexpectedly during an exam which may result in the total loss of real-time interventional imaging. the loss of the fluoro imaging capability may cause substantial harm to a patient, in case it happens during a "sensitive phase" of a coronary intervention.
  • Action
    GE Healthcare is advising users to ensure a quick functional check is performed before use. GE will be correcting all affected systems.

Device

INNOVA 2121IQ (Cardiovascular X-ray imaging system)

Manufacturer

GE Healthcare Australia Pty Ltd