Device Recall Responder 2023440 automated external defibrillator

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • 제조사 모회사 (2017)
  • Source
    USFDA