Events

Recall of Philips IntelliVue Information Centre (PIIC) iX

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Philips Medical Systems (USA).

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
    18025
  • Event Initiated Date
    2015-01-26
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Reason
    Sp02 and/or non invasive blood pressure (nbp) alarms may become disabled without visual notification to the user., a software defect has been identified that 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).
  • Action
    Software to be upgraded

Device

Philips IntelliVue Information Centre (PIIC) iX
  • Model / Serial
    Model: Part Numbers: 866023, 866024, 866117, Affected: , Software version: Revisions A.00, A.01, A.02
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

Philips Medical Systems (USA)
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA