Events

Recall of Philips Heartstart MRx Monitor/Defib

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
    13438
  • Event Initiated Date
    2012-09-03
  • 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: Laerdal (New Zealand) Ltd, Unit O, Cain Commerical Centre, 20 Cain Road, Penrose
  • Reason
    Due to corrupt data card some heartstart mrx defibrillator/monitors manufactured between 17-apr-2012 and 8-may-2012 may have incomplete 12 lead program files, and if so will present the following behaviour:, 1/ device cannot analyse a 12 lead ecg report. due to this a user cannot view, print or transmit a 12 lead ecg., 2/ a message "cannot analyse ecg' is displayed on the mrx when an attempt to acquire a 12 lead report is made.
  • Action
    Software to be upgraded

Device

Philips Heartstart MRx Monitor/Defib

Manufacturer

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