Events

Recall of GEM FLEX INTERFACE 16CH FIXED 3.0T P-CONNECTOR

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
    83128
  • Event Risk Class
    III
  • Event Initiated Date
    2016-02-09
  • 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
    Part of the cable assembly may overheat when the device is used. rarely this could result in minor burn injury in case of prolonged direct skin contact with the overheating part. there have been no injuries reported as a result of this issue.

Device

GEM FLEX INTERFACE 16CH FIXED 3.0T P-CONNECTOR
  • Model / Serial
    Model Catalog: NC032004 (Lot serial: 032E-4-0394); Model Catalog: NC032004 (Lot serial: 032E-4-0330); Model Catalog: NC032004 (Lot serial: 032E-4-0336); Model Catalog: NC032004 (Lot serial: 000032E-4-0041); Model Catalog: NC040000 (Lot serial: 034-4-0296); Model Catalog: NC034000 (Lot serial: 034-4-0296); Model Catalog: NC033000 (Lot serial: 040-4-0275); Model Catalog: NC033000 (Lot serial: 034-4-0296); Model Catalog: NC040000 (Lot serial: 033-4-0314); Model Catalog: NC034000 (Lot serial: 033-4-0314); Model Catalog: NC033000 (Lot serial: 033-4-0314); Model Catalog: NC040000 (Lot serial: 040-4-0315); Model Catalog: NC034000 (Lot serial: 040-4-0315); Model Catalog: NC033000 (Lot serial: 040-4-0315); Model Catalog: NC040000 (Lot serial: 0000034-4-0037); Model Catalog: NC034000 (Lot serial: 0000034-4-0037); Model Catalog: NC033000 (Lot serial: 0000034-4-0037); Model Catalog: NC040000 (Lot serial: 0000033-4-0044); Model Catalog: NC034000 (Lot serial: 0000033-4-0044); Model Catalog: NC033000 (Lot serial: 0000033-4
  • Product Description
    GEM FLEX INTERFACE 16CH FIXED 3.0T P-CONNECTOR;GEM FLEX COIL 3.0T RECEIVE ONLY
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)