Events

Recall of Philips Expression Information Portal (IP5) (secondary display control unit for the Expression MRI Patient Monitoring System)

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-01325-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-12-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01325-1
  • 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
    Upon power up, the ip5 may fail to produce audio. "audio" includes touch screen tones, qrs/spo2 modulation tones and audible alarms. all other functionality of the ip5 is unaffected (ie. waveforms, numeric values, visual alarm indications). this problem will only occur upon power up of the device. accordingly, the scenario where audio is present at the onset of monitoring and then is lost during monitoring will not occur.
  • Action
    Philips Healthcare is providing users work around instructions to follow as an interim measure. A software update will be installed to correct the problem.

Device

Philips Expression Information Portal (IP5) (secondary display control unit for the Expression MR...
  • Model / Serial
    Philips Expression Information Portal (IP5) (secondary display control unit for the Expression MRI Patient Monitoring System)Serial Numbers: US23200375, US23200376, US23200377 ARTG Number: 189095
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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