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
    13427
  • Event Initiated Date
    2012-08-31
  • 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
    Certain heartstart mrx monitor/defibrillators were manufactured with compromised components within the time frames of july 12, 2011 through september 2, 2011 and january 19, 2012 through may 22, 2012., may present the folowing behaviours:, a. in aed mode the mrx experiences difficulty interpreting pads ecg waveforms and may incorrectly analyze the waveform (potential for inappropriate therapy) or fail to anlyze the waveform., b. in manual mode the user may have trouble interpreting the pads ecg waveform and determining whether or not to deliver therapy. in addition the mrx may provide erroneous alarms or indicate an asystolic rhythm when paddles are not in patient cntact., c. if cpr meter is in use, users may not get an accurate impedance derived ventilation feedback.
  • Action
    Product to be modified

Device

Philips Heartstart MRx Monitor/Defib

Manufacturer

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