Recall Z-2328-2015— Philips Electronics North America Corporation

Name: FDA recall Z-2328-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-05

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2015-06-05, terminated 2019-02-25. It names one FDA 510(k) clearance: K110825. 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.. Reason: Multiple software and hardware issues with device that can affect its function..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-06-05
Terminated: 2019-02-25
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K110825 — PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODESPhilips Medical Systems·cleared 2012-02-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Multiple software and hardware issues with device that can affect its function.

Data sourced from openFDA. This site is unofficial and independent of the FDA.