Events

Recall of Philips HeartStart MRx Defibrillator/MonitorMRx unit types with software versions F.03.06 (M3535A) and T.00.05 (M3536A) and earlier

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-2015-RN-01079-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01079-1
  • 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
    Mrx model m3535a and model m3536a may stop the automated ready-for-use (rfu) test in an abnormal state when the device is turned off. if this occurs, the rfu indicator window displays a pattern that is not documented in the instructions for use (ifu) or service manual. if this pattern appears and the device is turned on, it will revert the rfu back to an hourglass, indication that it is fully functional in all monitoring and therapy modes. there is no clinical risk if the device that has displayed this rfu pattern is turned on and put into service. a device experiencing this issue will continue to run automated rfu test hourly and report a 0x00c000a4 code in the status log summary each time.
  • Action
    All MRx users should be informed that if the pattern appears, they can continue to use the device. Once the MRx is turned on, the pattern will disappear and the device will function normally in all monitoring and therapy modes. Philips will provide a software upgrade – for M3535A (software version F.03.07 or higher) and M3536A (software version T.00.06 or higher) – to correct this issue. A software upgrade will be provided free of charge for all affected products. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrades.

Device

Philips HeartStart MRx Defibrillator/MonitorMRx unit types with software versions F.03.06 (M3535A...
  • Model / Serial
    Philips HeartStart MRx Defibrillator/MonitorMRx unit types with software versions F.03.06 (M3535A) and T.00.05 (M3536A) and earlier Part Numbers: M3535A, M3535ATZ, M3536A, M3536ATZ, M3536J, M3536M, M3536M2, M3536M4, M3536M5, M3536M6, M3536MCARTG Number: 261352
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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