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
    16324
  • Event Initiated Date
    2014-03-07
  • 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
    An internal component on the heartstart mrx therapy board may malfunction potentially affecting the ability to deliver therapy. specifically, the mrx may be unable to charge and deliver a shock. in addition, when used for external pacing, the malfunction may result in a loss of capture during pacing., the mrx may display a red x in the ready for use (rfu) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing.
  • Action
    Product to be modified

Device

Philips Heartstart MRx Monitor/Defib

Manufacturer

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