Recall Z-1110-2014— Philips Medical Systems, Inc.

Name: FDA recall Z-1110-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-04

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-02-04, terminated 2020-09-03. It names one FDA 510(k) clearance: K051134. Product: Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC. Reason: HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers.

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-02-04
Terminated: 2020-09-03
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 used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC

Reason for recall

HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers

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