Philips Healthcare Inc.: Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: 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

Recall number

Z-1896-2012

Recalling firm

Philips Healthcare Inc.

Product

Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: 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

Status

Terminated

Initiated

2012-06-20

Posted

2012-06-27

Terminated

2017-03-16

Reason

HeartStart MRx Unexpected Pads/Paddles ECG Failure

Root cause

Process control

Action

Philips issued an Urgent Voluntary Medical Device Correction/Field Safety Notice letter on June 20, 2012. The letter informs customers of the issue, identifies details (including models and software versions applicable) of units affected, gives instructions on actions to be taken until the correction is available, and identifies what action Philips plans to eliminate or remedy the issue. The letter states that a Philips Healthcare representative will contact customers to arrange for the replacement of the Power PCA in all the affected devices. Philips will complete the installation free of charge. For questions or support concerning this issue contact your local Philips representative at 1-800-722-9377.

Quantity

2914 units

Distribution

Worldwide Distribution - US (nationwide) and the countries of: AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHINA, COLOMBIA, EL SALVADOR, ETHIOPIA, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOREA, REPUBLIC OF, LEBANON, LIBYAN ARAB JAMAHIRIYA, MEXICO, MOROCCO, NETHERLANDS, NETHERLANDS ANTILLES, NICARAGUA, NORWAY, PERU, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIET NAM.

Lot, serial or model codes

Manufactured between the dates of July 12, 2011 through September 2, 2011 and January 19, 2012 through May 22, 2012.  Serial numbers within the ranges of: US00550047 to US00551654 and US00556357 to US00559493 respectively.   There are also some additional MRx units that were repaired and may contain compromised components. These MRx unit serial numbers are identified below: US00210180, US00210183, US00210738, US00211000, US00213281 US00214706, US00316827, US00318163, US00319241, US00328491 US00329811, US00333101, US00536832, US00538140, US00543161 US00543825, US00544081, US00544214, US00546107, US00548046

510(k) numbers

["K051134"]

PMA numbers

not on file

Product code

MKJ

Firm FEI

1218950

Firm city

Andover

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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