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 details

Manufacturer

Philips Healthcare Inc.

Distributor

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

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

Risk classification

Class II

Area (FDA)

device

Country

United States