Z-1120-2014Class II

HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use...

Name: Z-1120-2014 HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use...
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 HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricular tachycardia and... on 2014-02-18. FDA classified it as Class II and gives the reason as "Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from RF energy source". 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-1120-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-18
Posted: 2014-02-26
Terminated: 2020-09-03
Recalling firm: Philips North America LLC
Product: HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from RF energy source
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Philips Healthcare, sent an "URGENT- Medical Device Correction" letter dated February 2014 and issued a Field Safety Notice on February 18/ 2014 to its customers. The letter and field safety notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips will replace the affected batteries free of charge. Philips instructed customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice. Fixed, portable, and mobile radio frequency communications equipment can affect the performance of medical equipment. See the HeartStart MRx Instructions for Use for the minimum recommended separation distance between RF communications equipment and the HeartStart MRx. The condition can be avoided by operating the device on AC or external DC power or by the following actions when operating on battery. If you need any further information or support concerning this issue, please contact your local Philips representative or call us at 1-800-722-9377.
Quantity in commerce: 43,792 batteries
Distribution: Worldwide Distribution: US (nationwide) and Internationally to: ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGUIM, BOLIVIA, BRAZIL, CANADA, CHINA, COLOMBIA, CONGO, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA REPUBLIC, KUWAIT, LATIVA, LEBANON, LIBYAN ARAB, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, MOZAMBIQUE, MYANMAR, NEPAL, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERAL, SAUDIA ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN PROVIDENCE, THAILAND, TRINIDAND AND TABAGO, TUNISIA, TURKEY, TURKMENISTANIA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, and VIETNAM.
Product codes and lots: Serial numbers: 11327-0019-P 11315-0023-P 11315-0027-P 11315-0031-P 11315-0032-P 11315-0033-P 11315-0036-P 11315-0109-P 11315-0214-P 11315-0219-P 11315-0391-P 11322-0084-P 11322-0088-P 11327-0043-P 11327-0044-P Or within the following range: 11335-xxxx-P to 13214-xxxx-P

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1120-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1120-2014	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)