Events

Recall of Philips HeartStart MRx Monitor/Defibrillator

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia Ltd.

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
    RC-2014-RN-00231-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-03-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00231-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • 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
    Philips is initiating a correction to the affected devices. A hardware upgrade will be provided to customers with affected devices. Philips is advising users that they can continue to use their MRx prior to receiving the hardware upgrade, provided that if it is observed that the MRx is displaying a Red X in the Ready For Use (RFU) indicator during automated tests, a failure has been detected that may prevent the delivery of a shock or pacing due to this issue. If this occurs, remove from use and call for a service. Identify a readily available back up defibrillator to use in the event the affected MRx fails to deliver therapy.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • Model / Serial
    Philips HeartStart MRx Monitor/DefibrillatorModel numbers: M3535A, M3536A, M3536M, M3536M4, M3536M6, 861288, 861289, 861464, 861483, and 861491Units Affected: Serial numbers within the range US00100204 to US00570921ARTG Number: 95661
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA