CLASS II Device recall · Reported 5 Mar 2014 · FDA Enforcement Report

Philips HeartStart MRx Monitor/Defibrillator used recalled

Philips Medical Systems is recalling Philips HeartStart MRx Monitor/Defibrillator used, distributed nationwide in the US. The recall was initiated on 4 Feb 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMRx 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

Quantity recalled58466 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1110-2014
FDA event ID: 67427
Recalling firm: Philips Medical Systems, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 4 Feb 2014
FDA classified: 26 Feb 2014
Reported: 5 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Pacemakers & Defibrillators

Timeline

4 Feb 2014	Recall initiated by company
26 Feb 2014	Classified by FDA	+22 days
5 Mar 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution: USA (nationwide) and to countries of: AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND France GERMANY GHANA GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KAZAKHSTAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS¿ LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACEDONIA MALAYSIA MEXICO MONGOLIA MOROCCO MOZAMBIQUE MYANMAR (Burma)¿ NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NORWAY OMAN PAKISTAN PALESTINE PANAMA PAPUA NEW GUINEA PARAGUAY PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SERBIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN

Nationwide Puerto Rico

Questions about this recall

Is Philips HeartStart MRx Monitor/Defibrillator used recalled?

Yes. Philips Medical Systems recalled Philips HeartStart MRx Monitor/Defibrillator used on 4 Feb 2014. The recall is Class II and its status is Terminated. Recall number Z-1110-2014.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Philips Medical Systems

All 81

Reported	Class	Recall	Company	Reason	Where
5 Aug 2026Device	CLASS II	Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro recalled	Philips Medical Systems	Device Malfunction	Nationwide
5 Aug 2026Device	CLASS II	Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP recalled	Philips Medical Systems	Device Malfunction	Nationwide
5 Aug 2026Device	CLASS II	IQon Spectral CT IQon Spectral CT Upgrades recalled	Philips Medical Systems	Device Malfunction	Nationwide
22 Apr 2026Device	CLASS II	Philips Spectral CT on Rails recalled by Philips Medical Systems	Philips Medical Systems	Device Malfunction	Nationwide
5 Nov 2025Device	CLASS II	Model: Incisive CT; Product Code (REF): (1) 728143, (2) recalled	Philips Medical Systems	Lead & Heavy Metals	Nationwide

Other Pacemakers & Defibrillators recalls

All 494

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	DermaV Laser System recalled by Lutronic	Lutronic	Other	Nationwide
1 Jul 2026Device	CLASS II	Convenience kits containing select SKUs of Polycarbonate recalled	Medline Industries	Other	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled	Medline Industries	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled	Medline Industries	Foreign Material	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled	Medline Industries	Device Malfunction	Nationwide