Events

Recall of HeartStart XL Defibrillator Battery / Monitor, model M3516A (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-2012-RN-00993-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-09-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00993-1
  • 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
    If the xl defibrillator/monitor (m4735a) is used on a patient when ac power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone.
  • Action
    Customers are being advised to identify whether they are using the defibrillators with a defective battery and to operate the affected HeartStart XL Defibrillator/Monitor using AC power supply only. Philips will be providing affected customers with a replacement battery(s) as soon as a new production of batteries are available.

Device

HeartStart XL Defibrillator Battery / Monitor, model M3516A (manual defibrillator).
  • Model / Serial
    HeartStart XL Defibrillator Battery / Monitor, model M3516A (manual defibrillator).Units Affected: HeartStart XL battery M3516A labelled with 'Made in Taiwan' and date of manufacture 'R-2011-12'ARTG Number : 95661
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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