Events

Recall of NEUROMUSCULAR TRANSMISSION MODULE

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
    128367
  • Event Risk Class
    II
  • Event Initiated Date
    2014-02-14
  • 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
    When the neuromuscular transmission (nmt) module e-nmt-01 is used in conjunction with the electrosensor the neuromuscular transmission values may indicate a deeper level of muscle relaxation than the actual level of muscle relaxation. this issue may lead to an inadequate dose of muscle relaxants. the issue may occur when the e-nmt-01 module is plugged into the carescape or the datex ohmeda s/5 anesthesia monitor.

Device

NEUROMUSCULAR TRANSMISSION MODULE

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)