Device Recall Philips Hearstart XL

  • Modelo / Serial
    Serial numbers within the range:  US00101665 through US00608704 Units manufactured by Philips between May, 2013 and November, 2013.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    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,
  • Descripción del producto
    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
  • 1 Event

Fabricante

  • Dirección del fabricante
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA