Home / Recalls / Medical Devices
Philips Medical Systems, Inc. recalls Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibril
Recalled March 5, 2014 · FDA recall Z-1109-2014 · Philips Medical Systems
Hazard
Philips HeartStart XL may experience a power board failure causing failure to defibrillate · FDA Class II
Units
5234 units
Sold at
Worldwide Distribution and USA Nationwide and the countries of AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, ETHIOPIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, KAZAKHSTAN, KOREA, REPUBLIC OF, MALAYSIA, MEXICO, MONACO, NEPAL, NETHERLANDS, PORTUGAL, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, and VIET NAM,
Description
Philips HeartStart XL may experience a power board failure causing failure to defibrillate
Product
Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the M4735A HeartStart XL Defibrillator/Monitor is suitable for use by medical personnel trained in basic life support that includes the use of an AED
Manufacturer(s)
Philips Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →