Company: Philips Electronics North America Corporation
Date of Enforcement Report 8/12/2015
Class lI:
PRODUCT
Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes the use of an AED. When operating in Monitor, Manual Defibrillation or Pacing modes, the HeartStart XL+ is suitable for use by healthcare professionals trained in advance life support.
Recall Number Z-2328-2015
REASON
Multiple software and hardware issues with device that can affect its function..
RECALLING FIRM/MANUFACTURER
hilips Electronics North America Corporation, Andover, MA on 6/5/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
13,168 devices
DISTRIBUTION
Nationwide and Internatonally
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