Philips Healthcare Inc.: Medical Device Recall in 2012 - (Recall #: Z-1896-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 20, 2012

Date Posted: July 4, 2012

Recall Number: Z-1896-2012

Event ID: 62333

Reason for Recall:

HeartStart MRx Unexpected Pads/Paddles ECG Failure

Status: Terminated

Product Quantity: 2914 units

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated