Events

Recall of ITS4850A INTELLIVUE TELEMETRY SYSTEM - 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
    92019
  • Event Risk Class
    II
  • Event Initiated Date
    2017-03-09
  • 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 discovered that under specific 802.11 network conditions a partial re-association of the mx40 wlan monitor to a compatible central monitoring system ("information center") is possible. in this state although the information center provides a visible and audible "no data tele" inop alert the mx40 wlan itself enters telemetry mode i.E. its screen turns off in one minute and local alarming is disabled.

Device

ITS4850A INTELLIVUE TELEMETRY SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: ITS4850A (Lot serial: >100 NUMBERS CONTACT MFG)
  • Product Description
    ITS4850A INTELLIVUE TELEMETRY SYSTEM-MAIN UNIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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