Device Recall Phillips HeartStart MRx Monitor/Defribillator

  • Modèle / numéro de série
    MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) and to countries of: ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA ECUADOR EGYPT FINLAND FRANCE GERMANY HONG KONG INDIA INDONESIA IRELAND ISRAEL ITALY KENYA KOREA, REPUBLIC OF KUWAIT LATVIA LIBYAN ARAB JAMAHIRIYA MALAYSIA MEXICO MOROCCO NETHERLANDS NORWAY OMAN PAKISTAN PHILIPPINES POLAND QATAR RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA THAILAND TURKEY UKRAINE UNITED ARAB EMIRATES and UNITED KINGDOM.
  • Description du dispositif
    Philips HeartStart MRx Monitor/Defibrillator || Models: M3535A and M3536A with Q-CPR Meter Option B08 || 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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Société-mère du fabricant (2017)
  • Source
    USFDA