Events

Recall of Philips Xper Flex Cardio Physiomonitoring System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Invivo, a division of Philips Medical Systems.

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
    23017
  • Event Initiated Date
    2018-05-24
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Reason
    A problem has been detected in the xper flex cardio patient monitoring system, it is possible for any of the following conditions to occur, which could result in delays in diagnosis or treatment:, 1. boom monitor (display) may not display all active waveform and/or vital sign data., 2. delayed audible and visual alarms at the flex cardio and boom monitor respectively, due to a mismatch between the alarm limits on the host system and the flex cardio/boom monitor., 3. after patient admission and case initiation at the host system, the case may not be fully transmitted to the flex cardio.
  • Action
    Instructions for use to be updated

Device

Philips Xper Flex Cardio Physiomonitoring System

Manufacturer

Invivo, a division of Philips Medical Systems
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA