Events

Recall of Philips IntelliVue Information Center iX (PIIC iX) software release A.01.XX (Central patient monitoring station)

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-2013-RN-00259-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-03-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00259-1
  • 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
    Philips has received a customer report that the piic ix (release a.01.Xx) central stations that are connected to a database server (dbs) may not be able to complete a restart/reboot resulting in the loss of central monitoring. this defect occurs when the following two criteria are met:1. the workflow for reviewing stored patient data on the piic ix involves the modification of the default trend scales in the retrospective review applications and these trend scales are customised for hundreds of different patients (within a period of seven days or less); and2. a planned/unplanned event resulting in the restart/reboot of the piic ix central stations (e.G. deliberate reboot, network connection to the dbs is lost and piic central stations go into local mode, power failure, etc.).
  • Action
    End users are provided with instructions to prevent the defect from occurring. A Philips Healthcare representative will contact customers with affected devices to arrange for the installation of updated PIIC iX software, resolving this issue on all affected units.

Device

Philips IntelliVue Information Center iX (PIIC iX) software release A.01.XX (Central patient moni...
  • Model / Serial
    Philips IntelliVue Information Center iX (PIIC iX) software release A.01.XX (Central patient monitoring station)ARTG Number: 94237
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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