Events

Recall of IntelliVie Information Centre (PIIC) iX (centralised patient monitor)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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
    RC-2015-RN-01226-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-12-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01226-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Calculated ecg leads, also referred to as reconstructed leads when viewed or printed at the information center ix, may misrepresent the ecg waveform morphology in some reconstructed leads. (the full set of six limb leads is commonly calculated from 2 limb leads.)following are the lead combinations that are affected.· lead i and lead iii-(avl incorrectly reconstructed)· lead i and lead avr-(avl lead incorrectly reconstructed)· lead iii and lead avf-(ii incorrectly reconstructed)with this combination and hexad on, the 4 derived v leads morphology will also be misrepresented in review applications.Trx/mx40 only – iii, v or avr, v (avl incorrectly reconstructed) review applications only.
  • Action
    Philips will be providing a software upgrade as a permanent correction. In the interm, users are informed that: - Arrhythmia alarms are not affected. ST alarms, ST values and measurements are also not affected and could be used to assist with the decision to obtain a diagnostic ECG. - The ECG waves at the bedside are not affected. Printing ECG waves from the bedside is an alternative to printing from the PIIC iX. Users are also advised that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.

Device

IntelliVie Information Centre (PIIC) iX (centralised patient monitor)
  • Model / Serial
    IntelliVie Information Centre (PIIC) iX (centralised patient monitor)Affected Systems:866023 IntelliVue Information Centre iX, A.0866389 IntelliVue Information Centre iX, B.0866117 PIIC Classic UpgradeARTG Number: 94237
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA