Recall Z-1118-2014— Philips Medical Systems, Inc.

Name: FDA recall Z-1118-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-18

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-02-18, terminated 2018-02-20. It names one FDA 510(k) clearance: K051134. Product: Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the termination of ventricular tachycardia and ventricular fibrillation.. Reason: ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal.

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-02-18
Terminated: 2018-02-20
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 Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the termination of ventricular tachycardia and ventricular fibrillation.

Reason for recall

ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal

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