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
    16323
  • 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Reason
    The ecg trunk cable and connector block of the mrx could be susceptible to accelerated wear, which could result in an interrupted ecg signal. interruption of the ecg signal can cause:, * loss of demand mode pacing, * inability to perform synchronized cardioversion with paddles, * disruption of leads ecg monitoring, which could delay appropriate treatment, defibrillation, fixed mode pacing, ecg monitoring via pads/paddles, and other monitoring functions are not impacted by this issue.
  • Action
    Product to be modified

Device

Philips HeartStart MRx Monitor/Defib
  • Model / Serial
    Model: Model Numbers: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC, Affected:
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

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