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-00209-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00209-1
  • 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
    An internal component on the heartstart xl power board may malfunction potentially affecting the ability to deliver therapy. specifically, the xl may be unable to charge and deliver a shock. in addition, when used for external pacing, the malfunction may result in a loss of capture.
  • Action
    Philips will be installing replacement power boards to correct the problem. A Philips representative will be in contact with customers to make arrangements for the correction. While awaiting the replacement power board for the device, users may continue to use the HeartStart XL. Identify a readily available backup defibrillator to use in the event the affected HeartStart XL fails to deliver therapy. This action has been closed-out on 11/02/2016.

Device

Philips HeartStart XL, Defibrillator/Monitor
  • Model / Serial
    Philips HeartStart XL, Defibrillator/MonitorModel Number: M4735AUnits Affected: Units manufactured by Philips between May, 2013 and November, 2013 Serial numbers within the range: US00101665 to US00608704
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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