Events

Recall of 1.5T SIGNA HDX MR 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
    153402
  • Event Risk Class
    II
  • Event Initiated Date
    2010-10-15
  • 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
    If gradient cables are inadvertently swapped while servicing and geometry check not performed as required in procedure images may be flipped left-right with incorrect orientation annotation.

Device

1.5T SIGNA HDX MR SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: M3335JG (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M3335J (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M3335JA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M3000TD (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M1800MA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M3333TD (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M1060YW (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M1060LG (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M1000RA/RD/RF/RG (Lot serial: ALL SERIAL NUMBERS); Model Catalog: DISCOVERY MR450 1.5T MR SYSTEM (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M3335JK (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M1000MA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M7000MC (Lot serial: ALL SERIAL NUMBERS); Model Catalog: S7504HP (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M7000MA (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    1.5T SIGNA HDX MR SYSTEM - MAIN UNIT
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)