Events

Recall of INNOVA IGS 520 IMAGE GUIDED SYSTEM - 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
    155330
  • Event Risk Class
    III
  • Event Initiated Date
    2013-04-18
  • 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
    After installing the diamentor m4-kdk the ge innova dose display may have been disabled using the instructions in the ge innova operator or service manual. however when installed the diamentor m4-kdk cannot continuously display the cumulative air kerma (cak) beyond 10gy whereas the cumulative dose value can exceed 10 gy during some critical/complex procedures.

Device

INNOVA IGS 520 IMAGE GUIDED SYSTEM - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)