Events

Recall of DISCOVERY IGS 740 - 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
    36798
  • Event Risk Class
    II
  • Event Initiated Date
    2016-04-20
  • 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
    The following issue is being addressed by ge healthcare file no. fmi 12246: ge healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of image acquisition. the affected discovery systems may experience multiple x-ray abort errors during a real-time interventional procedure. this issue could potentially happen before or during a fluoroscopic interventional procedure. there have been no injuries reported as a result of this issue.

Device

DISCOVERY IGS 740 - MAIN UNIT
  • Model / Serial
    Model Catalog: 5418813 (Lot serial: 0000HXED001318); Model Catalog: 5418813 (Lot serial: 0000HXED001317); Model Catalog: 5418813 (Lot serial: 0000HXED001320); Model Catalog: 5418812 (Lot serial: 0000HXE9001292)
  • Product Description
    DISCOVERY IGS 740;DISCOVERY IGS 730 SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)