Data Foundry

Medical device recalls 2014

Philips HeartStart MRx Monitor/Defibrillator used Model numbers:… — Class II medical device recall Z-1110-2014

Terminated recall by Philips Medical Systems, Inc., reported 2014-03-05, distributed nationwide. HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for pat

Recall numberZ-1110-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips Medical Systems, Inc., Andover, MA, United States
Recall initiated2014-02-04
Classified2014-02-26
Reported by FDA2014-03-05
Terminated2020-09-03
DistributedNationwide (US)
Countries outside the USAE, AF, AR, AT, AU, AW, BD, BE, BG, BH, BO, BR, CH, CL, CN, CO, CR, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GH, GR, HK, HR, ID, IE, IL, IN, IQ, IS, IT, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MX, MY, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SV, TH, TN, TR, TT, TW, UA, VE, VN, ZA
Quantity58,466 units
Serial numbersM3536A, M3536J, M3536M, M3536MC, USD0100104, USD0100902, USD0209838, USD0332675, USD0500002, USD0500009, USD0543688, USD0572207
Model numbersM3535A, M3536A, M3536J, M3536M, M3536MC

Product

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1110-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.