Device Recall Responder 2023440 automated external defibrillator

  • Modèle / numéro de série
    SERIAL NUMBERS: 900650, 900651, 900652, 900653, 900654, 900655, 900656, 900658, 900659, 900660, 900661, 900662, 900663, 900664, 900665, 900666, 900667, 900668, 900670, 900671, 900672, 900673, 900675, 900677, 900678, 900679, 900680, 900681, 900682, 900683, 900684, 900685, 900686, 900687, 900688, 900689, 900690, 900691, 900692, 900693, 900694, 900695, 900696, 900697, 900698, 900940, 900941, 900942, 900943, 900944, 900945, 900946, 900947, 900948, 901026, 901027, 901028, 901030, 901031, 901033, 901034, 901035, 901186, 901187, 901188, 901189, 901190, 901191, 901192, 901193, 901194, 901195, 901196, 901197, 901198, 901199, 901200, 901201, 901202, 901203, 901204, 901205, 901206, 901207, 901208, 901209, 901211, 901212, 901213, 901214, 901215, 901216, 901217, 901218, 901219, 901220, 901221, 901222, 901223, 901224, 901225, 901226, 901227, 901228, 901229, 901230, 901231, 901232, 901233, 901234, 901235, 901296, 901297, 901298, 901299, 901300, 901301, 901302, 901303, 901304, 901305, 901306, 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4201999, 4202000.4202001, 4202002, 4202003, 4202004, 4202005, 4202006, 4202007, 4202008, 4202009, 4202010, 4202011, 4202012, 4202013, 4202014, 4202015, 4202016, 4202017, 4202018, 4202019, 4202020, 4202021, 4202022, 4202023, 4202024, 4202025, 4202026, 4202027, 4218155, 4218156, 4218157, 4218158, 4218159, 4218160, 4218161, 4218162, 4218163, 4218164, 4218165, 4218166, 4218167, 4218168, 4218169, 4218170, 4218171, 4218172, 4218173, 4218174, 4218175, 4218176, 4218177, 4218178, 4218179, 4218180, 4218181, 4218182, 4218183, 4218184, 4218185, 4218186, 4218187, 4218188, 4218189, 4218190, 4218191, 4218192, 4218193, 4218194, 4218195, 4218196, 4218197, 4218198, 4218199, 4218200, 4218201, 4218202, 4218203, 4218204, 4218205, 4218206, 4218207, 4218208, 4218209, 4218210, 4218211, 4218212, 4218213, 4218214, 4218215, 4218216, 4218217, 4218218, 4218219, 4218220, 4218221, 4218222, 4218223, 4218224, 4218225, 4218226, 4218227, 4218228, 4218229, 4218230, 4218231, 4218232, 4218233, 4218234, 4218235, 4218236, 4218237, 4218238, 4218239, 4218240, 4218241, 4218242, 4218243, 4218244, 4218245, 4218246, 4218247, 4218248, 4218249, 4218250, 4218251, 4218252, 4218253, 4218254, 4218255, 4218256, 4218257, 4218258, 4218259, 4218260, 4218261, 4218262, 4218263, 4218264, 4218265, 4218266, 4218267, 4218268, 4218269, 4218270, 4218271, 4218272, 4218273, 4218274, 4218275, 4218276, 4218277, 4218278, 4218279, 4218280, 4218281, 4218282, 4218283, 4218284, 4218285, 4218286, 4218287, 4218288, 4218289, 4218290, 4218291, 4218292, 4218293, 4218294, 4218295, 4218296, 4218297, 4218298, 4218299, 4218300, 4218301, 4218302, 4218303, 4218304, 4218305, 4218306, 4218307, 4218308, 4218309, 4218310, 4218311, 4218312, 4218313, 4218314, 4218315, 4218316, 4218317, 4218318, 4218319, 4218320, 4218321, 4218322, 4218323, 4218324, 4218325, 4218326, 4218327, 4218328, 4218329, 4218330, 4218331, 4218332, 4218333, 4218334, 4218335, 4218336, 4218337, 4218338, 4218339, 4218340, 4218341, 4218342, 4218343, 4218344, 4218345, 4218346, 4218347, 4218348, 4218349, 4218350, 4218351, 4218352, 4218353, 4218354, 4218355, 4218356, 4218357, 4218358, 4218359, 4218360, 4218361, 4218362, 4218363, 4218364, 4218365, 4218366, 4218367, 4218368, 4218369, 4218370, 4218371, 4218372, 4218373, 4218374, 4218375, 4218376, 4218377, 4218378, 4218379, 4218380, 4218381, 4218382, 4218383, 4218384, 4218385, 4218386, 4218387, 4218388, 4218389, 4218390, 4218391, 4218392, 4218393, 4218394, 4218395, 4218396, 4218397, 4218398, 4218399, 4218400, 4218401, 4218402, 4218403, 4218404, 4252004, 4252005, 4252006, 4252007, 4252008, 4252009, 4252010, 4252011, 4252012, 4252013, 4252014, 4252015, 4252016, 4252017, 4252018, 4252019, 4252020, 4252021, 4252022, 4252023, 4252024, 4252025, 4252026, 4252027, 4252028, 4252029, 4252030, 4252031, 4252032, 4252033, 4252034, 4252035, 4252036, 4252037, 4252038, 4252039, 4252040, 4252041, 4252042, 4252043, 4252044, 4252045, 4252046, 4252047, 4252048, 4252049, 4252050, 4252051, 4252052, 4252053, 4258659, 4258660, 4258661, 4258662, 4258663, 4258664, 4258665, 4258666, 4258667, 4258668, 4258669, 4258670, 4258671, 4258672, 4258673, 4258675, 4258676, 4258680, 4258681, 4258682, 4258683, 4258684, 4258685, 4258686, 4258687, 4258688, 4258689, 4258690, 4258691, 4258693, 4258694, 4258695, 4258696, 4258697, 4258698, 4258699, 4258700, 4258702, 4258703, 4258705, 4258706, 4258707 AND 4258708.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- UNITED STATES, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, CZECHOSLOVAKIA, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GRECE, GUAM, GUATEMALA, HOLLAND, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, LIBYA, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONACO, MORROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SCOTLAND, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, VIRGIN ISLANDS AND YEMEN.
  • Description du dispositif
    GE Responder 2023440 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). || Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Société-mère du fabricant (2017)
  • Source
    USFDA