Recall Z-1189-2013— Philips Healthcare Inc.

Name: FDA recall Z-1189-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-08

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2013-04-08, terminated 2017-01-10. It names one FDA 510(k) clearance: K051134. Product: HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.. Reason: Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode..

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-04-08
Terminated: 2017-01-10
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

HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.

Reason for recall

Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode.

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