Events

Recall of Lithium Ion batteries used with 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-00195-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00195-1
  • 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
    The philips heartstart mrx monitor/defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from rf energy sources.
  • Action
    Philips is replacing all affected batteries. In the interim Philips is advising that shut down can be avoided by operating the device on AC or external DC power or by following the actions when operating on battery power: - before placing the MRx into use, insert a fully charged battery with five solid green lights on the battery fuel gage when the fuel gauge button is pressed - If your device does not power on, press the fuel gauge button and verify that at least one solid green light is illuminated. If there are no lights, insert a fully charged MRx battery.

Device

Lithium Ion batteries used with Philips HeartStart MRx Monitor/Defibrillator
  • Model / Serial
    Lithium Ion batteries used with Philips HeartStart MRx Monitor/DefibrillatorMRx Serial Numbers: 11327-0019-P, 11315-0032-P, 11315-0214-P, 11322-0088-P, 11315-0023-P, 11315-0033-P, 11315-0219-P, 11327-0043-P, 11315-0027-P,11315-0036-P, 11315-0391-P, 11327-0044-P, 11315-0031-P, 11315-0109-P, 11322-0084-P, 11322-0088-PARTG Number: 95661
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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