Device Recall Responder 2019198 automated external defibrillator

SERIAL NUMBERS: 331444, 331468, 331488, 331493, 331496, 331511, 331519, 336294, 336304, 336310, 337095, 337114, 337115, 337120, 337121, 337122, 337123, 337124, 337126, 337127, 337128, 337129, 337130, 337131, 337133, 337134, 337135, 337136, 337137, 337138, 337139, 337140, 337143, 337149, 337152, 337156, 337165, 337168, 337781, 343501, 343502, 343503, 343504, 343505, 343506, 343507, 343508, 343509, 343510, 343511, 343512, 343513, 343514, 343515, 343516, 343517, 343518, 343519, 343520, 343521, 343522, 343523, 343524, 343525, 343526, 343527, 343528, 343529, 343530, 343531, 343532, 343533, 343534, 343535, 343536, 343537, 343538, 343539, 343540, 343542, 343543, 343544, 343545, 343546, 343547, 343548, 343549, 343550, 343551, 343552, 343553, 343554, 343555, 343556, 343557, 343558, 343559, 343560, 343562, 343563, 343564, 343565, 343566, 343567, 343568, 343569, 343570, 343571, 343572, 343573, 343574, 343575, 343576, 343577, 343578, 343579, 343580, 343581, 343582, 343583, 343584, 343585, 343586, 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4203701, 4203702, 4203703, 4203704, 4203705, 4203706, 4203707, 4203708, 4203709, 4203710, 4203711, 4203712, 4203713, 4203714, 4203715, 4203716, 4203717, 4203718, 4203719, 4203720, 4203721, 4203722, 4203723, 4203724, 4203725, 4203726, 4203727, 4203728, 4203729, 4203730, 4203731, 4203732, 4203733, 4203734, 4203735, 4203736, 4203737, 4203738, 4203739, 4203740, 4203741, 4203742, 4203743, 4203744, 4203745, 4203746, 4203747, 4203748, 4203749, 4203750, 4203751, 4203752, 4203753, 4203754, 4203755, 4203756, 4203757, 4203758, 4203759, 4203760, 4203761, 4203762, 4203763, 4203764, 4203765, 4203766, 4203767, 4203768, 4203769, 4203770, 4203771, 4203772, 4203773, 4203774, 4203775, 4203776, 4203777, 4203778, 4203779, 4208280, 4208281, 4208282, 4208283, 4208284, 4208285, 4208286, 4208287, 4208288, 4208289, 4208290, 4208291, 4208292, 4208293, 4208294, 4208295, 4208296, 4208297, 4208298, 4208299, 4208300, 4208301, 4208302, 4208303, 4208304, 4208305, 4208306, 4208307, 4208308, 4208309, 4208310, 4208311, 4208313, 4208314, 4208315, 4208316, 4208317, 4208318, 4208319, 4208320, 4208321, 4208322, 4208323, 4208324, 4208325, 4208326, 4208327, 4208328, 4208329, 4208330, 4208331, 4208332, 4208333, 4208334, 4208335, 4208336, 4208337, 4208338, 4208339, 4208340, 4208341, 4208342, 4208343, 4208344, 4208345, 4208346, 4208347, 4208348, 4208349, 4208350, 4208351, 4208352, 4208353, 4208354, 4208355, 4208356, 4208357, 4208358, 4208359, 4208360, 4208361, 4208362, 4208363, 4208364, 4208365, 4208366, 4208367, 4208368, 4208369, 4208370, 4208371, 4208372, 4208373, 4208374, 4208375, 4208376, 4208377, 4208378, 4208379, 4208380, 4208381, 4208382, 4208383, 4208384, 4208385, 4208386, 4208387, 4208388, 4208389, 4208390, 4208391, 4208392, 4208393, 4208394, 4208395, 4208396, 4208397, 4208398, 4208399, 4208400, 4208401, 4208402, 4208403, 4208404, 4232754, 4232755, 4232756, 4232757, 4232758, 4232759, 4232760, 4232761, 4232762, 4232763, 4232764, 4232765, 4232766, 4232767, 4232768, 4232769, 4232770, 4232771, 4232772, 4232773, 4232774, 4232775, 4232776, 4232777, 4232778, 4232779, 4232780, 4232781, 4232782, 4232783, 4232784, 4232785, 4232786, 4232787, 4232788, 4232789, 4232790, 4232791, 4232792, 4232793, 4232794, 4232795, 4232796, 4232797, 4232798, 4232799, 4232800, 4232801, 4232802, 4232803, 4232804, 4232805, 4232806, 4232807, 4232808, 4232809, 4232810, 4232811, 4232812, 4232813, 4232814, 4232815, 4232816, 4232817, 4232818, 4232819, 4232820, 4232821, 4232822, 4232823, 4232824, 4232825, 4232826, 4232827, 4232828, 4232829, 4232830, 4232831, 4232832, 4232833, 4232834, 4232835, 4232836, 4232837, 4232838, 4232839, 4232840, 4232841, 4232842, 4232843, 4232844, 4232845, 4232846, 4232847, 4232848, 4232849, 4232850, 4232851, 4232852, 4232853, 4236104, 4236105, 4236106, 4236107, 4236108, 4236109, 4236110, 4236111, 4236112, 4236113, 4236114, 4236115, 4236116, 4236117, 4236118, 4236119, 4236120, 4236121, 4236122, 4236123, 4236124, 4236125, 4236126, 4236127, 4236128, 4236129, 4236130, 4236131, 4236132, 4236133, 4236134, 4236135, 4236136, 4236137, 4236138, 4236139, 4236140, 4236141, 4236142, 4236143, 4236144, 4236145, 4236146, 4236147, 4236148, 4236149, 4236150, 4236151, 4236152, 4236153, 4236154, 4236155, 4236156, 4236157, 4236158, 4236159, 4236160, 4236161, 4236162, 4236163, 4236164, 4236165, 4236166, 4236167, 4236168, 4236169, 4236170, 4236171, 4236172, 4236173, 4236174, 4236175, 4236176, 4236177, 4236178, 4236179, 4236180, 4236181, 4236182, 4236183, 4236184, 4236185, 4236186, 4236187, 4236188, 4236189, 4236190, 4236191, 4236192, 4236193, 4236194, 4236195, 4236196, 4236197, 4236198, 4236199, 4236200, 4236201, 4236202, 4236203, 4236204, 4236205, 4236206, 4236207, 4236208, 4236209, 4236210, 4236211, 4236212, 4236213, 4236214, 4236215, 4236216, 4236217, 4236218, 4236219, 4236220, 4236221, 4236222, 4236223, 4236224, 4236225, 4236226, 4236227, 4236228, 4236229, 4236230, 4236231, 4236232, 4236233, 4236234, 4236235, 4236236, 4236237, 4236238, 4236239, 4236240, 4236241, 4236242, 4236243, 4236244, 4236245, 4236246, 4236247, 4236248, 4236249, 4236250, 4236251, 4236252, 4236253, 4236254, 4236255, 4236256, 4236257, 4236258, 4236259, 4236260, 4236261, 4236262, 4236263, 4236264, 4236265, 4236266, 4236267, 4236268, 4236269, 4236270, 4236271, 4236272, 4236273, 4236274, 4236275, 4236276, 4236277, 4236278, 4236279, 4236280, 4236281, 4236282, 4236283, 4236284, 4236285, 4236286, 4236287, 4236288, 4236289, 4236290, 4236291, 4236292, 4236293, 4236294, 4236295, 4236296, 4236297, 4236298, 4236299, 4236300, 4236301, 4236302, 4236303, 4249804, 4249805, 4249806, 4249807, 4249808, 4249809, 4249810, 4249811, 4249812, 4249813, 4249814, 4249815, 4249816, 4249817, 4249818, 4249819, 4249820, 4249821, 4249822, 4249823, 4249824, 4249825, 4249826, 4249827, 4249828, 4249829, 4249830, 4249831, 4249832, 4249833, 4249834, 4249835, 4249836, 4249837, 4249838, 4249839, 4249840, 4249841, 4249842, 4249843, 4249844, 4249845, 4249846, 4249847, 4249848, 4249849, 4249850, 4249851, 4249852, 4249853, 4249854, 4249855, 4249856, 4249857, 4249858, 4249859, 4249860, 4249861, 4249862, 4249863, 4249864, 4249865, 4249866, 4249867, 4249868, 4249869, 4249870, 4249871, 4249872, 4249873, 4249874, 4249875, 4249876, 4249877, 4249878, 4249879, 4249880, 4249881, 4249882, 4249883, 4249884, 4249885, 4249886, 4249887, 4249888, 4249889, 4249890, 4249891, 4249892, 4249893, 4249894, 4249895, 4249896, 4249897, 4249898, 4249899, 4249900, 4249901, 4249902, 4249903, 4254509, 4254510, 4254511, 4254512, 4254513, 4254514, 4254515, 4254516, 4254517, 4254518, 4254519, 4254520, 4254521, 4254522, 4254523, 4254524, 4254525, 4254526, 4254527, 4254528, 4254529, 4254530, 4254531, 4254532, 4254533, 4254534, 4254535, 4254536, 4254537, 4254538, 4254539, 4254540, 4254541, 4254542, 4254543, 4254544, 4254545, 4254546, 4254547, 4254548, 4254549, 4254550, 4254551, 4254552, 4254553, 4254554, 4254555, 4254556, 4254557, 4254558, 4254559, 4254560, 4254561, 4254562, 4254563, 4254564, 4254565, 4254566, 4254567, 4254568, 4254569, 4254570, 4254571, 4254572, 4254573, 4254574, 4254575, 4254576, 4254577, 4254578, 4254579, 4254580, 4254581, 4254582, 4254583, 4254584, 4254585, 4254586, 4254587, 4254588, 4254589, 4254590, 4254591, 4254592, 4254593, 4254594, 4254595, 4254596, 4254597, 4254598, 4254599, 4254600, 4254601, 4254602, 4254603, 4254604, 4254605, 4254606, 4254607, 4254608, 4265996, 4265997, 4265998, 4265999, 4266000, 4266001, 4266002, 4266003, 4266004, 4266005, 4266006, 4266007, 4266008, 4266009, 4266010, 4266011, 4266012, 4266013, 4266014, 4266015, 4266016, 4266017, 4266018, 4266019, 4266020, 4266021, 4266022, 4266023, 4266024, 4266025, 4266026, 4266027, 4266028, 4266029, 4266030, 4266031, 4266032, 4266033, 4266034, 4266035, 4266036, 4266037, 4266038, 4266039, 4266040, 4266041, 4266042, 4266043, 4266044, 4266045, 4266046, 4266047, 4266048, 4266049, 4266050, 4266051, 4266052, 4266053, 4266054, 4266055, 4266056, 4266057, 4266058, 4266059, 4266060, 4266061, 4266062, 4266063, 4266064, 4266065, 4266066, 4266067, 4266068, 4266069, 4266070, 4266071, 4266072, 4266073, 4266074, 4266075, 4266076, 4266077, 4266078, 4266079, 4266080, 4266081, 4266082, 4266083, 4266084, 4266085, 4266086, 4266087, 4266088, 4266089, 4266090, 4266091, 4266092, 4266093, 4266094, 4266095, 4266646, 4266647, 4266648, 4266649, 4266650, 4266651, 4266652, 4266653, 4266654, 4266655, 4266656, 4266657, 4266658, 4266659, 4266660, 4266661, 4266662, 4266663, 4266664, 4266665, 4266666, 4266667, 4266668, 4266669, 4266670, 4266671, 4266672, 4266673, 4266674, 4266675, 4266676, 4266677, 4266678, 4266679, 4266680, 4266681, 4266682, 4266683, 4266684, 4266685, 4266686, 4266687, 4266688, 4266689, 4266690, 4266691, 4266692, 4266693, 4266694, 4266695, 4266696, 4266697, 4266702, 4266703, 4266704, 4266705, 4266706, 4266716, 4266717, 4266723, 4266726, 4266727, 4266728, 4266729, 4266730, 4266731, 4266732, 4266733, 4266734, 4266735, 4266736, 4266745, 4266746, 4266747, 4266769 AND  4266795.

Cardiovascular Devices

3

No

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.

GE Responder 2019198 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.