Events

Recall of 1.5T SIGNA INFINITY TWINSPEED WITH EXCITE

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
    24038
  • Event Risk Class
    II
  • Event Initiated Date
    2009-09-09
  • 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
    Use of cadstream with "pure" software for dynamic mri imaging may require a modification to the study preference settings to present colour overlays equivalent to non-pure studies.

Device

1.5T SIGNA INFINITY TWINSPEED WITH EXCITE
  • Model / Serial
    Model Catalog: M3000TD (Lot serial: MANUFACTURER); Model Catalog: M3000TD (Lot serial: >10 NUMBERS); Model Catalog: M3000TD (Lot serial: CONTACT); Model Catalog: M3000LF (Lot serial: 274168MR4 270572MR1); Model Catalog: M7000BF (Lot serial: S/N'S 291192MR3 290992MR7); Model Catalog: M3000LF (Lot serial: S/N'S HDMR10368 7547YR3); Model Catalog: M3000LF (Lot serial: 278606MR9 266072MR8); Model Catalog: 2294302 (Lot serial: 253630MR8 239043MR3); Model Catalog: 2294302 (Lot serial: S/N'S 243409MR0 239046MR6); Model Catalog: 2294302 (Lot serial: 256216MR3 246610MR0); Model Catalog: 2294302 (Lot serial: 258415MR9 247728MR9); Model Catalog: 2294302 (Lot serial: 242181MR6); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: S/N 30BD4960); Model Catalog: M3333TA (Lot serial: S/N'S 6690YR2 266690MR7); Model Catalog: M3335PB (Lot serial: >10 NUMBERS); Model Catalog: M3335PB (Lot serial: CONTACT); Model Catalog: M3335PB (Lot serial: MANUFACTURER); Model Catalog: M3335JK (Lot serial: S/N 7555YR6)
  • Product Description
    1.5T SIGNA INFINITY TWINSPEED EXCITE
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)