Events

Recall of INTELLIVUE M40 PATIENT MONITOR SYSTEM - MULTI MEASUREMENT SERVER

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
    51330
  • Event Risk Class
    II
  • Event Initiated Date
    2006-08-01
  • 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 using with some types of disposable sensors an spo2 saturation level of 100% may be displayed even though the sensor is not attached to the patient potentially causing user to miss a desaturation event.

Device

INTELLIVUE M40 PATIENT MONITOR SYSTEM - MULTI MEASUREMENT SERVER
  • Model / Serial
    Model Catalog: M3001A (Lot serial: >1000 devices); Model Catalog: M3001A (Lot serial: contact manufacturer)
  • Product Description
    SEE 33-01
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC