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
    32599
  • Event Risk Class
    III
  • Event Initiated Date
    2013-04-25
  • 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 screen save images are included in a wrong exam due to duplicate uid (unique identifier) creation. this may cause a safety issue due to a potential patient data mismatch.This issue occurs when all of the following criteria are met: performed procedure step (pps) is enabledtwo screen save series generated on study instanceuid starting with 1.X and 2.X respectively with pps status set as "defer" for both if these series are transferred to a cpsi pacs both of them would show up under the same patient study instanceuid starting with 1.X.

Device

1.5T SIGNA HDX MR SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: M3335J (Lot serial: ); Model Catalog: M3335JA (Lot serial: ); Model Catalog: M3335JB (Lot serial: ); Model Catalog: M3335JG (Lot serial: ); Model Catalog: M3000TD (Lot serial: ); Model Catalog: M3335AG (Lot serial: ); Model Catalog: M3335JK (Lot serial: ); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: ); Model Catalog: M1060LG (Lot serial: ALL); Model Catalog: M3000CB (Lot serial: )
  • Product Description
    1.5T Signa HDX MR System
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)