Recall Z-2157-2020— Philips North America, LLC

Name: FDA recall Z-2157-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-27

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2020-04-27, terminated 2021-07-19. It names one FDA 510(k) clearance: K051134. Product: Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.. Reason: HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections.

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-04-27
Terminated: 2021-07-19
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/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.

Reason for recall

HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections

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