Events

Recall of INTELLIVUE MP30 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
    81233
  • Event Risk Class
    II
  • Event Initiated Date
    2015-01-04
  • 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 become aware that the hexad 12-lead ecg monitoring derivation uses a 6-lead set and derives remaining leads to provide a non-diagnostic 12-lead view including ecg waves and st measurements. the st elevation alarm on the patient monitor or standalone x2 measurement module will not sound when indicated for all chest leads derived using hexad 12-lead ecg monitoring in the host monitor configuration below: st analysis: "off" ste: "on" ste alarms: "on".

Device

INTELLIVUE MP30 PATIENT MONITOR SYSTEM - MULTI MEASUREMENT SERVER
  • Model / Serial
    Model Catalog: M3001A (Lot serial: ALL); Model Catalog: M3002A (Lot serial: ALL)
  • Product Description
    INTELLIVUE MP30 PATIENT MONITOR SYSTEM-MULTI MEASUREMENT SERVER
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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