Events

Recall of Philips Expression Information Portal - IP5 (Multiparameter 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-2013-RN-01052-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-10-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01052-1
  • 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
    If an ip5 is in use or powered on for an extended period of time (exceeding 24 hours), the ip5 may lost all audio function. "all audio" includes touch screen and qrs/spo2 modulation tones and audible alarms. all other functionality of the ip5 is unaffected (waveforms, numeric values, visual alarm indications).
  • Action
    A Philips representative will contact the affected customer to arrange for a software update to correct the problem. End users are requested to power cycle the IP5 once every 24 hours and to be aware not to rely solely on audible alarms for alerting of potentially critical patient events.

Device

Philips Expression Information Portal - IP5 (Multiparameter patient monitor)

Manufacturer

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