Events

Recall of Philips Intellivue Patient Monitor X3

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-2017-RN-01518-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01518-1
  • 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 discovered that the nbp measurement of x3 intermittently displays only mean values instead of the diastolic and systolic blood pressure values. furthermore, occasionally the monitor shows the ‘check touch input” message, indicating that the touchscreen controls may not function.
  • Action
    Philips will distribute a software update for the affected devices and replace the display assembly. Philips has provided a workaround until the corrections are implemented. Users should consider using an alternative monitor in situations where the touchscreen controls are needed when using the X3 in standalone mode.

Device

Philips Intellivue Patient Monitor X3

Manufacturer

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