Events

Recall of INTELLIVUE MX550 PATIENT MONITOR

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
    26981
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-25
  • 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
    Philips has recently determined that when certain patient monitors (mx400 mx450 mx500 and mx550) have been powered on continuously for at least three months the waveforms displayed on the monitor may be outdated and therefore fail to reflect the patient's current condition. should this occur however the monitor's alarms and numeric displays of vital signs will continue to function as specified and accurately reflect current patient data.

Device

INTELLIVUE MX550 PATIENT MONITOR
  • Model / Serial
    Model Catalog: 866066 (Lot serial: NA); Model Catalog: 866062 (Lot serial: NA); Model Catalog: 866064 (Lot serial: NA); Model Catalog: 866060 (Lot serial: NA)
  • Product Description
    INTELLIVUE MX550 PATIENT MONITOR;INTELLIVUE MX450 PATIENT MONITOR;INTELLIVUE MX500 PATIENT MONITOR;INTELLIVUE MX400 PATIENT MONITOR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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