Events

Recall of INTELLIVUE - INFORMATION CENTER CLIENT

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
    55300
  • Event Risk Class
    II
  • Event Initiated Date
    2011-01-14
  • 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
    Users have replaced keyboards supplied or approved by philips with multi-media-type keyboards which have an audio volume adjustment and muting controls. this allows users to easily mute audio alarms on the intellivue information center or to reduce their volume. the alarm audio volume on beside monitors and client devices connected to the intellivue information center is not affected. although the service and installation guide includes warnings about the use of hardware and software not supplied by philips it does not specify that ignoring the warning can result in loss of alarm annunciation or in the impairment of central patient monitoring.

Device

INTELLIVUE - INFORMATION CENTER CLIENT
  • Model / Serial
    Model Catalog: M3151B (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: M3145 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: M3150 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: M3155 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: M3140 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: M3150A (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: M3153A (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: M3170 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: M3154 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    INTELLIVUE-INFORMATION CENTER CLIENT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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