Events

Recall of INNOVA 4100IQ - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    101168
  • Event Risk Class
    III
  • Event Initiated Date
    2012-02-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Innova operator manual states that the air kerma ratio between the "low" and "normal" mode of operation during fluoroscopy exposure shall remain below 50% of normal detail mode forfluoroscopy. ge healthcare became aware of a potential issue on a specific fluoro mode setting rdl (auto-exposure preference) for which the "low" to "normal" dose rate ratio might be higher than 50% at very low dose level (6.7 mgy/min versus limit at 43.8 mgy/min) with 7.5 fps and 15 fps. as a result this issue raised a regulatory non-conformance concern. ge healthcare has completed upgrades to all affected units through software field actions thereby correcting the issue.

Device

INNOVA 4100IQ - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)