Events

Recall of Philips HeartStart XL+ Defibrillator / Monitor (manual 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-2013-RN-00156-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-02-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00156-1
  • 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 xl+ defibrillator/monitor may fail to power on in clinical mode and instead power on in service mode, displaying an "equipment disabled: therapy" prompt, requiring the user to enter a password and perform an operational check to clear the condition. the device will not return to clinical mode until an operational check has been performed.
  • Action
    A Philips representative with contact customers with affected devices to arrange for a software update. Until the correction is implemented the device can continue to be used by following work around procedures.

Device

Philips HeartStart XL+ Defibrillator / Monitor (manual defibrillator)
  • Model / Serial
    Philips HeartStart XL+ Defibrillator / Monitor (manual defibrillator)Model Number: 861290Serial Number ranges:USO1100100–USO1100372US61201722–US61201924USN1100376–USN1100960US71201925–US71202048USD1100961–USD1101095US81202049–US81202168US11201096–US11201186US91202169–US91202514US21201187–US21201239USO1202515–USO1202990US31201240–US31201537USN1202991–USN1203537US41201538–US41201585USD1203538–USD1203968US51201586–US51201721US11303969–US11303972
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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