Events

Recall of Philips Intellivue MX40 Electrocardiography Monitoring System

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

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
    16876
  • Event Initiated Date
    2014-06-23
  • 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
    Intellivue mx40 is set in monitor mode with the philips intellivue infirmation centre ix when using the pause alarms feature in the non-default configuration. the alarms paused condition remains indefinitely unless alarming is manually restarted by deselecting the pause alarm button at the mx40 or at the piic ix., there is potential for the alarms paused banner to go unnoticed and an alarm condition will not be audibly heard potentially resulting in a delay of treatment.
  • Action
    Software to be upgraded

Device

Philips Intellivue MX40 Electrocardiography Monitoring System

Manufacturer

Philips Medical Systems (USA)
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA