Events

Recall of MR APPLICATIONS

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
    17414
  • Event Risk Class
    III
  • Event Initiated Date
    2013-08-19
  • 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
    Cardiacvx and cardiacvx flow report higher than actual flow values on phase-contrast images acquired with magnitude weighting mask enabled. note that this issue can only occur on phase contrast mr protocols with the magnitude weighting mask option enabled. in the fast cine phase-contrast sequence the magnitude weighting mask is a user configurable option (control variable or cv). in the 2d cine phase-contrast sequence (non-fast mode) magnitude weighting mask is always on and thus would always result in this issue. the issue may result in an incorrect diagnosis if higher than actual flow values are not noticed.

Device

MR APPLICATIONS
  • Model / Serial
    Model Catalog: 5434388-X (Lot serial: 00000L0240862D); Model Catalog: 5434388-X (Lot serial: 00000287170GE5); Model Catalog: 5434388-X (Lot serial: 00000287171GE3); Model Catalog: 5434388-X (Lot serial: 00000322015GE9); Model Catalog: 5434388-X (Lot serial: 00000328735GE6); Model Catalog: 5434388-X (Lot serial: 00000281269GE1)
  • Product Description
    CARDIACVX
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)