Events

Recall of INTELLIVUE MP2 PATIENT MONITOR - MAIN UNIT

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
    23146
  • Event Risk Class
    II
  • Event Initiated Date
    2010-08-27
  • 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 received reports that speakers on the philips intellivue x2 and mp2 patient monitors have failed prematurely. this failure may be identified by the display of a "speaker malfunct." inop or by the absence of audible sound. speaker failures may delay recognition of an alarm condition if operators do not recognize that there is no alarm sound from the monitor and the monitor is not connected to another audible alarm annunciation system e.G. another bedside monitor or a central monitoring station.

Device

INTELLIVUE MP2 PATIENT MONITOR - MAIN UNIT
  • Model / Serial
    Model Catalog: M8102A (Lot serial: DE95008060); Model Catalog: M8102A (Lot serial: DE95008046); Model Catalog: M8102A (Lot serial: DE95008062); Model Catalog: M8102A (Lot serial: DE95008063); Model Catalog: M8102A (Lot serial: DE95008067); Model Catalog: M8102A (Lot serial: DE95008076); Model Catalog: M3002A (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    INTELLIVUE MP2 PATIENT MONITOR - MAIN UNIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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