RecallRadar

FDA Device recall Z-1110-2014

Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC

On 2014-03-05 the FDA classified a Class II recall of Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC by Philips Medical Systems, citing heartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1110-2014
ClassificationClass II
Statusterminated
Initiated2014-02-04
Published2014-03-05
Last updated2026-09-13 11:53 UTC
CompanyPhilips Medical Systems
DistributionUS

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

Identifiers

code_info
MRx devices and serial numbers within the following ranges: M3535A Serial Numbers: USD0100104 - USD0572207; M3536A…MRx devices and serial numbers within the following ranges: M3535A Serial Numbers: USD0100104 - USD0572207; M3536A Serial Numbers: USD0100902 - USD0543688; M3536J Serial Numbers USD0209838 - USD0332675; M3536M Serial Numbers: USD0500002 - USD0500009; M3536MC Serial Nukmbers: USD0500002 - USD0500028

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1110-2014%22

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