Events

Recall of Philips IntelliVue Information Centre (PIIC)

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
    19578
  • Event Initiated Date
    2015-12-15
  • 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
    Calcualated leads, also referred to as reconstructed ecg leads viewed or printed at the information centre ix may misrepresent the ecg waveform in specific leads., lead combinations that are affected:, lead 1 and lead 111 are used to derive the avl lead (incorrectly derived), lead 1 and lead avr are used to derive the avl lead (incorrecty derived)', lead 111 and lead avf are used to derive lead 11 (incorrecty derived).
  • Action
    Software to be upgraded

Device

Philips IntelliVue Information Centre (PIIC)
  • Model / Serial
    Model: 866023 Intellivue Info Center iX, 866117 PIIC Classc Upgrade and 866389 IntelliVue Info Center iX, Affected: all versions
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

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