Recall of INTELLIVUE NMT PATIENT CABLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

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
    137629
  • Event Risk Class
    II
  • Event Initiated Date
    2017-04-28
  • Event Country
  • 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
    A small number of intellivue nmt patient cables may contain a localized isolation defect in the shielding of the acceleration sensor housing. this manufacturing defect may cause localized heating due to an unintended current flow between the acceleration sensor housing attached to the patient thumb and the nmt stimulation electrode connection attached to the wrist of the same hand.

Device

  • Model / Serial
    Model Catalog: 989803174581 (Lot serial: >100 numbers contact mfg)
  • Product Description
    Intellivue NMT Patient Cable
  • Manufacturer

Manufacturer

  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
  • Source
    HC