Recall Z-1986-2012— Philips Healthcare Inc.

Name: FDA recall Z-1986-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-20

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2012-06-20, terminated 2013-08-14. It names one FDA 510(k) clearance: K051134. Product: Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. Reason: Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG.

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-06-20
Terminated: 2013-08-14
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 MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician

Reason for recall

Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG

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