Events

Recall of NIM-2XL NERVE INTEGRITY MONITORING SYSTEM-2XL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by XOMED CANADA INC..

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
    65825
  • Event Risk Class
    II
  • Event Initiated Date
    2000-07-28
  • 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 device may fail to function or exhibit intermittent function during use.

Device

NIM-2XL NERVE INTEGRITY MONITORING SYSTEM-2XL
  • Model / Serial
    Model Catalog: 82-20201 (Lot serial: 18216300 18768300 18829400); Model Catalog: 82-20201 (Lot serial: 19609700 20164700); Model Catalog: 82-20201 (Lot serial: 19033600 19271900 19601100)
  • Product Description
    NIM-2NIM PATIENT INTERFACEPROTECTED PI
  • Manufacturer
    XOMED CANADA INC.

Manufacturer

XOMED CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Source
    HC