Events

Recall of Xper Flex Cardio 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-2015-RN-01105-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01105-1
  • 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
    The spo2 and non-invasive blood pressure (nibp) waveform and numeric values displayed on the device may freeze, resulting in the display of measurements that are not current. should this problem occur, spo2 and nibp will no longer function, including alarms. this may result in a delay in detecting important changes in a patient’s cardiovascular and respiratory condition.
  • Action
    Philips is advising users that the devices can continue to be used provided that each monitored patient is closely observed by a qualified healthcare professional. A software upgrade will be installed on all affected devices as a permanent correction.

Device

Xper Flex Cardio Patient Monitoring System
  • Model / Serial
    Xper Flex Cardio Patient Monitoring SystemModel Numbers: FC2010 and FC2020All systems distributed prior to September 2015ARTG Number: 229631
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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