Events

Recall of Philips HeartStart XL+ Defibrillator

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Philips Medical Systems (USA).

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
    18773
  • Event Initiated Date
    2015-07-06
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Reason
    Philips has identifed the following xl+ software and hardware issues:, , software:, * the xl+ may fail to complete the power on sequence and continuously reboot., * the xl+ may either fail to power up or may shut down unexpectedly., * the xl+ may have a software version that did not reset a fail-safe monitoring component which could cause a delay of therapy or pacing interruption., * the xl+ may fail to generate verbal prompts in aed mode., , hardware:, * the speaker may fail., * the battery may not seat properly causing the xl+ to shut down unexpectedly or remain powered on and not acknowledge or charge the battery., * the xl+ exceeds the allowable radiated emissions level for class b cispr11., * the xl+ ecg signal from leads could be lost and unrecoverable., * the xl+ spo2 signal may lose communication and cause the device to reboot., * the xl+ battery detection system may be disrupted and cause a false low battery alarm.
  • Action
    Product to be modified

Device

Philips HeartStart XL+ Defibrillator
  • Model / Serial
    Model: 861290, Affected: Serial number ranges: USO1100100 to USD1101095, US11201096 to USD1203968, US11303969 to USD1309471, US11409472 to US61414022
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

Philips Medical Systems (USA)
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA