Events

Recall of INTELLIVUE - INFORMATION CENTER IX - SOFTWARE

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
    51642
  • Event Risk Class
    II
  • Event Initiated Date
    2014-12-17
  • 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
    A software defect that could potentially result in a drop in oxygenation (hypoxia) that is not immediately detected by the clinician. defect involves the use of the "change bed label" feature at the information center ix. if the configuration for this item is set to "optional" and a user selects the "location" button within the "manage patient" menu and makes a change to the patient location alarms for sp02 and/or non invasive blood pressure (nbp) will become disabled without visual notification (bell with an "x") to the user. this problem only happens when the patient is monitored using a networked intellivue trx telemetry m4841/trx4851a patient worn device (pwd).

Device

INTELLIVUE - INFORMATION CENTER IX - SOFTWARE
  • Model / Serial
    Model Catalog: M3290B (Lot serial: 866117); Model Catalog: M3290B (Lot serial: 866023)
  • Product Description
    Phillips IntelliVue Information Centre (PIIC) iX
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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