Events

Recall of Philips IntelliVue Information Centre and Philips IntelliVue Information Centre iX (Central patient monitor unit)

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-2012-RN-01261-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-12-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01261-1
  • 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
    An internal audio cable connector may have diminished retention force due to damaged contacts. this diminished retention force may lead to intermittent or loss of audible alarms.
  • Action
    As an interim measure, Philips is advising users not to rely on the audible alarm from the central unit and to report any issues identified. A permanent fix is being implemented to replace the contacts that might cause the problem.

Device

Philips IntelliVue Information Centre and Philips IntelliVue Information Centre iX (Central patie...
  • Model / Serial
    Philips IntelliVue Information Centre and Philips IntelliVue Information Centre iX (Central patient monitor unit)ARTG number: 94237
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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