Events

Recall of Philips IntelliVue Patient Monitors

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-2016-RN-01025-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01025-1
  • 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 affected patient monitor has been powered on continuously for several months, any displayed waveforms will contain out-dated data and therefore fail to reflect the patient’s current condition. even if out-dated waveforms are displayed as a result of this problem, the monitor’s alarms and numeric displays of vital signs will continue to function as specified and accurately reflect current patient data. the length of time that a monitor must be powered on before the problem occurs depends on the selected wave speed. it ranges from 102 days (@50 mm/s) to 820 days (@ 6,25 mm/s), and is approximately 205 days at the monitor’s default wave speed of 25 mm/s. the monitor must be powered off in order to avoid this problem. simply placing it in stand-by mode is not sufficient. please note that connected devices, such as central monitors continue to display the correct wave data.
  • Action
    Philips Healthcare is advising users to cycle the power on the affected devices on a monthly basis. A software upgrade will be implemented as a permanent correction.

Device

Philips IntelliVue Patient Monitors
  • Model / Serial
    Philips IntelliVue Patient MonitorsModel Numbers: MX400, MX430, MX450, MX500, MX550Product Codes: 866060, 866061, 866062, 8066064, 866066ARTG Number: 213953
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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