Z-1118-2014Class II

Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC...

Name: Z-1118-2014 Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC...
Creator: Philips Medical Systems, Inc.
Published: 2014-02-18
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-02-18 / Terminated / root cause: design

FDA source

Philips Medical Systems, Inc. began a recall of Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the termination of ventricular tachycardia... on 2014-02-18. FDA classified it as Class II and gives the reason as "ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1118-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-18
Posted: 2014-02-26
Terminated: 2018-02-20
Recalling firm: Philips North America LLC
Product: Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the termination of ventricular tachycardia and ventricular fibrillation.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal
Root cause tag: design
FDA root cause: Component design/selection
Action: Philips Healthcare issued Urgent Medical Device Correction notification/Field Safety Notice on 2/18/14 informs customers of the issue and identifies what action Philips plans to take to remedy the issue. Philips will perform a hardware upgrade free of charge. Philips is asking customers to follow theAction to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: You can continue to use your MRx prior to receiving the hardware upgrade, while remaining aware that if the problem were to occur you could experience the following symptoms: Loss of demand mode pacing, nability to perform synchronized cardioversion with paddle andDisruption of ECG monitoring or INOP messages. Not every serial number within the listed range is affected by this Medical Device Correction. If you have questions about whether your MRx is affected by this issue, please contact Philips at 1-800-722-9377.
Quantity in commerce: 49929 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT ESTONIA ETHIOPIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAYSIA MALTA MEXICO MOROCCO NAMIBIA NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN PAKISTAN PANAMA PAPUA NEW GUINEA PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN.
Product codes and lots: Serial numbers within the range: US00100100 through US00550668

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1118-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1118-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-26

Product code MKJ

K051134Class IIIHeartstart Mrx with Q-CPR Option, Models M3535a or M3536aPhilips Medical Systems / cleared 2005-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)