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Philips Healthcare Inc. recalls Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage:
Recalled July 4, 2012 · FDA recall Z-1896-2012 · Philips Healthcare
Hazard
HeartStart MRx Unexpected Pads/Paddles ECG Failure · FDA Class II
Units
2914 units
Sold at
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.
Description
HeartStart MRx Unexpected Pads/Paddles ECG Failure
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
Manufacturer(s)
Philips Healthcare Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →