Device Recall Philips HeartStart XL Defibrillator/Monitor

  • Modèle / numéro de série
    Serial number range: USO1100100 - USO1100372,  USN1100376 - USN1100960, USD1100961 - USD1101095,  US11201096 - US11201186,  US21201187 - US21201239,  US31201240 - US31201537,  US41201538 - US41201585,  US51201586 - US51201721,  US61201722 -US61201924,  US71201925 - US71202048,  US81202049 - US81202168, US91202169- US91202514,  USO1202515 - USO1202990,  USN1202991 - USN1203537,  USD1203538- USD1203968,  US11303969 - US11303972
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to ALGERIA, ANGOLA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BULGARIA, COLOMBIA, CROATIA (LOCAL NAME HYVATSKA), CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GABON, GERMANY, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MAURITIUS, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, AND VIET NAM.
  • Description du dispositif
    Philips HeartStart XL+ Defibrillator/Monitor || Model number: 861290 || The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Société-mère du fabricant (2017)
  • Source
    USFDA