Events

Recall of Philips HeartStart XL+ Defibrillator/Monitor

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-00477-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00477-1
  • 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
    A software communication failure on the heartstart xl+ that occurs during an automated ready-for-use test or at turn-on may lock the user out of clinical mode, which may delay therapy. the communication error can trigger a false failure condition - error code 1:34 "equipment disable: therapy". if the user is locked out of clinical mode, a delay in therapy may occur, which could pose a risk for patients.
  • Action
    Philips is providing a software update to correct the issue. End users are advised while awaiting the software upgrade for the affected device users may continue to use the HeartStart XL+ unless the device exhibits a Red X, presents an audio chirp and displays the user message: “Equipment Disabled: Therapy”. This is an indicator that the device self-test has detected the problem and is not ready for use. In the case the problem cannot be resolved by running Op-Check, users should identify a readily available backup defibrillator to use in the event the affected HeartStart XL+ exhibits the communication failure. This action has been closed-out on 01/02/2016.

Device

Philips HeartStart XL+ Defibrillator/Monitor
  • Model / Serial
    Philips HeartStart XL+ Defibrillator/MonitorModel Number: 861290.Units upgraded to B.00.01 software, or manufactured by Philips between December, 2013 and February, 2014Multiple serial numbers affectedARTG Number: 95661
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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