Recall Z-1109-2014— Philips Medical Systems, Inc.

Name: FDA recall Z-1109-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-14

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-02-14, terminated 2016-06-16. It names one FDA 510(k) clearance: K051134. Product: Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the M4735A HeartStart XL Defibrillator/Monitor is suitable for use by medical personnel trained in basic life support that includes the use of an AED. Reason: Philips HeartStart XL may experience a power board failure causing failure to defibrillate.

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-02-14
Terminated: 2016-06-16
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K051134 — HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536APhilips Medical Systems·cleared 2005-09-08

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 Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the M4735A HeartStart XL Defibrillator/Monitor is suitable for use by medical personnel trained in basic life support that includes the use of an AED

Reason for recall

Philips HeartStart XL may experience a power board failure causing failure to defibrillate

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