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-00112-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-02-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00112-1
  • 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 battery may take slightly longer to charge to 100% at 35 deg c than specified in the instructions for use (ifu).
  • Action
    Philips is providing users with an addendum to the Instructions for Use (IFU) specifying the battery charge time and temperature specifications. The addendum specifies the proper battery charge time with the device turned off and PC power connectors i.e., with temperature at 25 deg C (77 deg F), it will take less than 3 hours to charge at100% capacity and less than 2 hours to charge at 80% capacity.

Device

Philips HeartStart XL+ Defibrillator/Monitor
  • Model / Serial
    Philips HeartStart XL+ Defibrillator/Monitor Model number 861290Multiple Serial Numbers affectedARTG Number: 95661
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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