Events

Recall of ITS4850A INTELLIVUE TELEMETRY SYSTEM - 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
    22710
  • Event Risk Class
    II
  • Event Initiated Date
    2014-05-23
  • 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 intellivue mx40 system (part numbers 865350 865351 865352) with software revisions b.00 or b.01 may not resume alarming when the alarms are paused and the pause timer ends. this issue will only occur when teh mx40 device is in monitor mode connected to a philips intellivue information center ix (piic ix) that is not in a specific default configuration.

Device

ITS4850A INTELLIVUE TELEMETRY SYSTEM - MONITOR
  • Model / Serial
    Model Catalog: MX40 (Lot serial: >1000 numbers contact mfg.)
  • Product Description
    ITS4850A INTELLIVUE TELEMETRY SYSTEM - MOINITOR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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