GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction

Summary

The FDA issued a Class II for GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603 by GE Medical Systems Information Technologies Inc. Reason: GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (.

Details

Product Description

GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Lot/Code Info: no UDI, Serial Number or Sales Order Number: KSA7013962, KSA5646256, KSA5646267, KSA5646268, KSA5646321, KSA5646328, KSA5646242, KSA5646251, KSA5646257, KSA5646284, KSA5646289, KSA5646295, KSA5646297, KSA5646306, KSA5646314, KSA6689326, KSA6689333, KSA6689378, KSA7162600, KSA7162603, KSA7162619, KSA7162631, KSA7769614, KSA6017390, KSA6569811, KSA6569814, KSA6569816, KSA6569853, KSA6569856, KSA6569866, KSA6569875, KSA6569879, KSA6569896, KSA7162612, KSA7162623, KSA7162662, KSA6409156, KSA6409176, KSA6409177, KSA6409181, KSA6420012, KSA6420057, KSA6420088, KSA6420106, KSA7013897, KSA5646292, KSA6409244, KSA7162605, KSA6808884, KSA7304364, KSA7304449, KSA7304452, KSA6590164, KSA7304435, KSA6954216, KSA6954221, KSA6626645, KSA6689380, KSA6808843, KSA6808843, KSA6808873, KSA6808874, KSA6808897, KSA6808897, KSA6623262, KSA6945167, KSA6017455, KSA7096908, KSA7096928, KSA7096932, KSA7096935, KSA7096940, KSA7096941, KSA7096946, KSA7096959, KSA7096971, KSA7096976, KSA7096985, KSA7096986, KSA7096994, KSA7550169, KSA7304426, KSA6017413, KSA6420074, KSA7442867, KSA7520473, KSA6945379, KSA7495811, KSA7495812, KSA7495828, KSA7495833, KSA6623187, KSA6623188, KSA6623208, KSA6623241, KSA6623249, KSA6623265, KSA6623273, KSA6623282, KSA6664042, KSA6017434, KSA6017505, KSA6664062, KSA6664066, KSA7162592, KSA5646252, KSA7304361, KSA7304418, KSA6689310, KSA6689342, KSA7391408, KSA7391483, KSA7442814, KSA7442876, KSA5646246, KSA6017327, KSA6017337, KSA6017411, KSA6017418, KSA6017452, KSA7574793, KSA6899017, KSA6899063, KSA7013916, KSA7013926, KSA7013985, KSA6945142, KSA6945304, KSA7509846, KSA7509848, KSA7520466, KSA7520486, KSA7716910, KSA7716914, KSA7744944, KSA6409155, KSA6420064, KSA6626658, KSA6808891, KSA6808910, KSA7162609, KSA7304373, KSA7304430, KSA7162584, KSA7239702, KSA7304389, KSA7304427, KSA7304450, KSA7550170, KSA7590261, KSA7590265, KSA7590268, KSA7391447, KSA6590189, KSA6626712, KSA5646253, KSA5646280, KSA7495807, KSA7495816, KSA7495829, KSA6017341, KSA6017348, KSA6017362, KSA6017380, KSA6017469, KSA6017481, KSA5646296, KSA5646275, KSA5646276, KSA5646299, KSA5646307, KSA5646322, KSA6945203, KSA7442837, KSA7442886, KSA6590183, KSA7120771, KSA6945201, KSA7590244, KSA7590250, KSA7590255, KSA7667331, KSA5646244, KSA5646285, KSA5646287, KSA5646293, KSA5646301, KSA5646302, KSA5646305, KSA5646320, KSA5646330, KSA6945295, KSA6017345, KSA6017349, KSA6017354, KSA6017427, KSA6017482, KSA6017493, KSA6017500, KSA6017507, KSA6808932, KSA6017359, KSA6477222, KSA7509839, KSA7509841, KSA6964881, KSA6964929, KSA6590131, KSA6590148, KSA6590150, KSA6590165, KSA6590167, KSA6590171, KSA6590180, KSA6590182, KSA6590193, KSA6590196, KSA6590217, KSA6590220, KSA7442861, KSA6899014, KSA7716916, KSA7716917, KSA7716935, KSA6419990, KSA6420003, KSA6017330, KSA7550164, KSA7574776, KSA7239690, KSA7239706, KSA7239713, KSA6536472, KSA6536494, KSA6536534, KSA7676886, KSA7744939, KSA7744956, KSA6409197, KSA6409202, KSA6409203, KSA6409211, KSA6409217, KSA6409230, KSA6409240, KSA6409253, KSA6536445, KSA6536537, KSA7162660, KSA6420022, KSA6808878, KSA7716911, KSA7716912, KSA7716915, KSA7716919, KSA7716921, KSA7716932, KSA6899010, KSA6899041, KSA6899042, KSA6899076, KSA7304363, KSA7304440, KSA7442799, KSA7442817, KSA7442818, KSA7442821, KSA7442827, KSA7442838, KSA7442858, KSA7442870, KSA7442881, KSA7442891, KSA7485738, KSA7485755, KSA7485758, KSA7485761, KSA7485763, KSA7495820, KSA7495824, KSA7495825, KSA6649175, KSA6649203, KSA5646271, KSA5646298, KSA5646325, KSA5646250, KSA7442779, KSA7442784, KSA7442819, KSA7442830, KSA7442850, KSA7442853, KSA7442863, KSA6623220, KSA6623274, KSA7391414, KSA7391430, KSA7391453, KSA7391491, KSA6945297, KSA6945372, KSA6409167, KSA6017315, KSA6017503, KSA6536511, KSA6569838, KSA7716922, KSA7716926, KSA7716931, KSA7716937, KSA7716909, KSA7716930, KSA6623221, KSA6866913, KSA6866940, KSA6866941, KSA6866948, KSA6866964, KSA5646283, KSA5646313, KSA6017351, KSA6017365, KSA6017376, KSA6017463, KSA7509834, KSA6017334, KSA6017343, KSA6017381, KSA6017419, KSA6664060, KSA6017401, KSA6017312, KSA6569891, KSA6017346, KSA6017347, KSA6017369, KSA6017374, KSA6017375, KSA6017399, KSA6017443, KSA6017446, KSA6017448, KSA7536142, KSA7550148, KSA7550157, KSA7550161, KSA7550163, KSA7574770, KSA7574771, KSA7574777, KSA7574782, KSA7574787, KSA7574791, KSA7574792, KSA6017453, KSA5646248, KSA5646259, KSA5646272, KSA5646274, KSA5646291, KSA5646300, KSA5646316, KSA5646319, KSA7391404, KSA7391410, KSA7391418, KSA7391464, KSA7391478, KSA7391480, KSA7391490, KSA7391495, KSA6017400, KSA6017350, KSA6017364, KSA7590248, KSA7590253, KSA7590254, KSA7773445, KSA6689312, KSA6017395, KSA6964950, KSA7013907, KSA7013959, KSA7442804, KSA6866971, KSA6649205, KSA6649268, KSA6623250, KSA6419997, KSA6420001, KSA6420091, KSA6420110, KSA7239654, KSA7239710, KSA6477237, KSA7724019, KSA7724026, KSA7724032, KSA7724035, KSA7724036, KSA7724046, KSA7724047, KSA7727675, KSA7727676, KSA7727688, KSA7732499, KSA7732500, KSA7732512, KSA7732513, KSA7732516, KSA7732525, KSA6964962, KSA7013977, KSA6964958, KSA6409164, KSA6409165, KSA6409179, KSA6409206, KSA6409219, KSA6409220, KSA6409225, KSA6409231, KSA6409233, KSA6536524, KSA6569868, KSA6420077, KSA6945270, KSA6626686, KSA6419991, KSA6420020, KSA6420026, KSA6420089, KSA6866925, KSA6866951, KSA6866984, KSA6866991, KSA6866993, KSA6808937, KSA7013946, KSA7013950, KSA6477210, KSA7013906, KSA7096922, KSA7096927, KSA7096942, KSA7096947, KSA7096950, KSA7096955, KSA7096957, KSA7096964, KSA7096968, KSA7096970, KSA7096972, KSA7097001, KSA6623205, KSA6623259, KSA6409205, KSA6409249, KSA7096924, KSA7096953, KSA7096961, KSA7096979, KSA7096980, KSA7509852, KSA6649206, KSA6664044, KSA7239734, KSA7162650, KSA6017316, KSA6017319, KSA6017449, KSA6017461, KSA6017502, KSA7754405, KSA7773434, KSA6409213, KSA6409238, KSA6409241, KSA6420083, KSA6017331, KSA6017454, KSA6409159, KSA6409208, KSA7442777, KSA7442780, KSA7442813, KSA7442852, KSA6017329, KSA6017332, KSA7304421, KSA7391493, KSA7442781, KSA7442789, KSA7442800, KSA7442822, KSA7442836, KSA7442847, KSA7442848, KSA7442856, KSA7442862, KSA7162653, KSA7724043, KSA7744953, KSA7744961, KSA7754386, KSA7754390, KSA7754400, KSA7769608, KSA7769613, KSA7769617, KSA7773416, KSA7773417, KSA6017414, KSA7120743, KSA7120752, KSA7120724, KSA6409221, KSA7304411, KSA7304425, KSA6419998, KSA6590216, KSA6409173, KSA6954219, KSA6954224, KSA6954227, KSA6954234, KSA6954246, KSA6954250, KSA6954256, KSA6954271, KSA6954275, KSA6954279, KSA6954295, KSA6590136, KSA7120758, KSA6409186, KSA6409242, KSA6964898, KSA6017487, KSA7520460, KSA7520463, KSA7520467, KSA7520474, KSA7520481, KSA7520482, KSA6420103, KSA6808857, KSA6808887, KSA7013901, KSA5646310, KSA6017484, KSA6899040, KSA6899043, KSA6899073, KSA7391435, KSA7391486, KSA6017442, KSA6866935, KSA7574783, KSA7574794, KSA6808861, KSA6808876, KSA6808900, KSA6477097, KSA6477139, KSA6477143, KSA6477161, KSA6477168, KSA6477208, KSA6477234, KSA6017441, KSA6420028, KSA6420096, KSA7162626, KSA7162638, KSA7391406, KSA7391413, KSA7391450, KSA6663999, KSA6664089, KSA5646270, KSA5646304, KSA6477128, KSA6420019, KSA6420115, KSA6536502, KSA6945144, KSA5646260, KSA5646309, KSA6409227, KSA6409235, KSA7391443, KSA7391446, KSA7391463, KSA7391468, KSA6964949, KSA6689349, KSA7013968, KSA7509830, KSA7520489, KSA6964903, KSA6964919, KSA6964968, KSA7304444, KSA7304459, KSA6866954, KSA6866986, KSA6689291, KSA6689356, KSA6689365, KSA6866904, KSA6866917, KSA6866938, KSA6866952, KSA6866961, KSA6866968, KSA6017366, KSA6017412, KSA6017423, KSA6017485, KSA7716936, KSA6017456, KSA6626646, KSA6626698, KSA6626704, KSA7391475, KSA6477104, KSA6477111, KSA6477124, KSA6409163, KSA6409223, KSA6409228, KSA6569804, KSA6569812, KSA6569846, KSA6017372, KSA6017392, KSA6017422, KSA6017429, KSA6017490, KSA5646286, KSA5646326, KSA6017483, KSA6017509, KSA6409172, KSA6590178, KSA6590190, KSA6649183, KSA6954218, KSA6954235, KSA6954288, KSA6964908, KSA6964954, KSA6964957, KSA6689299, KSA6689329, KSA6689338, KSA6689343, KSA6689370, KSA7120770, KSA7120778, KSA7162565, KSA7162565, KSA7162572, KSA7162572, KSA6689284, KSA6689316, KSA6689366, KSA7495813, KSA7769596, KSA6945206, KSA6945261, KSA6945342, KSA6954240, KSA6954243, KSA6954255, KSA6954278, KSA6954283, KSA6954286, KSA6954297, KSA6954301, KSA6954303, KSA6954307, KSA6954310, KSA6954313, KSA7716929, KSA6409161, KSA6409195, KSA7304366, KSA7013895, KSA7013939, KSA7013949, KSA7013953, KSA7013967, KSA7013976, KSA7013980, KSA7013984, KSA7096905, KSA7096918, KSA7096931, KSA7096943, KSA7096945, KSA7096958, KSA7096963, KSA7096977, KSA7096998, KSA7096999, KSA7097000, KSA5646241, KSA7239655, KSA6626654, KSA6626681, KSA6626696, KSA7162637, KSA6017317, KSA6017396, KSA6017402, KSA6626623, KSA6964891, KSA6964942, KSA6964947, KSA6420078, KSA6664000, KSA6420039, KSA6663995, KSA6866966, KSA6649244, KSA6649247, KSA5646317, KSA5646327, KSA6017440, KSA7304368, KSA7304371, KSA7304381, KSA7442843, KSA6954254, KSA6954263, KSA6954267, KSA6954290, KSA6954296, KSA6954311, KSA6536459, KSA6536459, KSA6663993, KSA6420024, KSA5646266, KSA6409169, KSA6409171, KSA6409215, KSA6477116, KSA6477183, KSA6945356, KSA6866909, KSA6866922, KSA6866932, KSA6866943, KSA6866947, KSA6866965, KSA6866988, KSA6866998, KSA6954217, KSA6954236, KSA6954265, KSA6954272, KSA6954292, KSA6954306, KSA6954308, KSA6954312, KSA7727687, KSA7304443, KSA7754385, KSA7754396, KSA7754401, KSA7769593, KSA7769606, KSA7769621, KSA7773433, KSA7773439, KSA7773443, KSA6964876, KSA6964877, KSA7120723, KSA6664024, KSA6664026, KSA6664043, KSA6664070, KSA6664074, KSA6808850, KSA6808904, KSA6626668, KSA6626668, KSA6626679, KSA6626679, KSA6626705, KSA6626705, KSA6626708, KSA6626708, KSA6964951, KSA7013952, KSA7495835, KSA6017470, KSA6808851, KSA6808923, KSA7442782, KSA7442887, KSA5646245, KSA5646262, KSA5646277, KSA5646303, KSA5646308, KSA5646318, KSA6017313, KSA6017320, KSA6017328, KSA6017339, KSA6017355, KSA6017356, KSA6017426, KSA6017444, KSA6017462, KSA6017467, KSA6017474, KSA6017475, KSA6017491, KSA6017494, KSA6017498, KSA6017499, KSA6017511, KSA6649266, KSA6649257, KSA6808909, KSA7096903, KSA7096903, KSA7096904, KSA7096904, KSA7162618, KSA7162661, KSA7239673, KSA7239738, KSA7162602, KSA7162616, KSA7162625, KSA7162634, KSA7239709, KSA7239740, KSA7239747, KSA7727703, KSA7732507, KSA7162577, KSA6017428, KSA6866934, KSA6964872, KSA6866994, KSA6945334, KSA7162582, KSA7162587, KSA7716920, KSA7716924, KSA7716927, KSA7304386, KSA7304388, KSA7304391, KSA7304392, KSA7304394, KSA7304409, KSA7304432, KSA7304434, KSA7304448, KSA6866923, KSA7391415, KSA7391436, KSA7391439, KSA7391440, KSA7391452, KSA7391461, KSA7495826, KSA6409187, KSA7304387, KSA7304455, KSA7304457, KSA5646288, KSA5646315, KSA6866907, KSA6866955, KSA6964897, KSA6590162, KSA6664076, KSA6477142, KSA6477177, KSA6477205, KSA6477248, KSA6808896, KSA6808920, KSA7304378, KSA7304383, KSA7304390, KSA7304393, KSA7304398, KSA7304403, KSA7304415, KSA7304447, KSA7304453, KSA7442790, KSA7120735, KSA7550162, KSA7120694, KSA6536503, KSA6536516, KSA5646282, KSA6649241, KSA6017447, KSA6689295, KSA7013917, KSA7013935, KSA7442883, KSA7162630, KSA6689287, KSA6689374, KSA5646258, KSA5646294, KSA5646323, KSA6017451, KSA6964873, KSA6964888, KSA6964904, KSA6964905, KSA6964944, KSA6964946, KSA6964961, KSA6964965, KSA7013896, KSA7013969, KSA6017342, KSA6017460, KSA6017468, KSA6899012, KSA6899065, KSA7520476, KSA6808931, KSA6808846, KSA6808898, KSA6945367, KSA6964902, KSA6623246, KSA6623253, KSA6623258, KSA6626685, KSA6626702, KSA6964870, KSA7574765, KSA7550160, KSA7574768, KSA7391419, KSA7391422, KSA7391498, KSA7550166, KSA6649221, KSA7304422, KSA6017322, KSA6017358, KSA6017397, KSA6017439, KSA6626710, KSA7391489, KSA7442873, KSA7391407, KSA7391462, KSA7391482, KSA7442778, KSA7442871, KSA7442880, KSA6590125, KSA7162624, KSA6409180, KSA7162596, KSA7754391, KSA6409198, KSA6899023, KSA6899024, KSA6899038, KSA6899049, KSA6899068, KSA6899069, KSA6899083, KSA6899088, KSA6017338, KSA6409188, KSA6808892, KSA6808892, KSA6808933, KSA6808933, KSA6017344, KSA6017415, KSA6017420, KSA6017430, KSA6689339, KSA7391501, KSA7391481, KSA6664040, KSA6664067, KSA7509837, KSA7509845, KSA7509851, KSA7509855, KSA7509856, KSA7509857, KSA7304441, KSA7391456, KSA7391477, KSA7442874, KSA7485743, KSA7485745, KSA7485750, KSA7485752, KSA5646261, KSA7716913, KSA7716923, KSA7716925, KSA7716928, KSA7716933, KSA7716934, KSA7716938, KSA7304365, KSA7391496, KSA7442786, KSA7442801, KSA7442878, KSA6017479, KSA6017497, KSA7495808, KSA7495809, KSA7495814, KSA7495815, KSA7495819, KSA7495821, KSA7495823, KSA7495827, KSA7495830, KSA7495831, KSA7495834, KSA7495836, KSA7509843, KSA7509850, KSA7509853, KSA7520468, KSA7520471, KSA7520475, KSA7442787, KSA7442828, KSA7442854, KSA7442892, KSA7120688, KSA6664025, KSA6945104, KSA6569900, KSA6945110, KSA6945325, KSA6945330, KSA7724023, KSA7732503, KSA6409234, KSA6536514, KSA6945153, KSA7013892, KSA7013894, KSA7013900, KSA7013915, KSA7013933, KSA7013937, KSA7013938, KSA7013943, KSA6689292, KSA6689296, KSA6689297, KSA6689315, KSA6689332, KSA6689359, KSA6689369, KSA6945158, KSA6945293, KSA6945207, KSA6945259, KSA6945364, KSA7442816, KSA7442851, KSA6477098, KSA6477113, KSA6477126, KSA6477163, KSA6477191, KSA6945098, KSA6945172, KSA7120696, KSA5646254, KSA6626682, KSA6964871, KSA6964874, KSA6964889, KSA6964892, KSA6964899, KSA6964935, KSA6964943, KSA6964959, KSA6945103, KSA6945105, KSA6945115, KSA6945122, KSA6945137, KSA6945138, KSA6945161, KSA6945169, KSA6945170, KSA6945174, KSA6945184, KSA6945195, KSA6945197, KSA6945200, KSA6945218, KSA6945221, KSA6945233, KSA6945237, KSA6945240, KSA6945267, KSA6945272, KSA6945280, KSA6945285, KSA6945286, KSA6945292, KSA6945309, KSA6945313, KSA6945324, KSA6945337, KSA6945345, KSA6945347, KSA6945348, KSA6945371, KSA6945386, KSA6964909, KSA6964915, KSA6964917, KSA6964939, KSA6964952, KSA6017326, KSA6017340, KSA6017353, KSA6017363, KSA6017379, KSA6017389, KSA6017425, KSA6017432, KSA6017438, KSA6945136, KSA6945320, KSA6964967, KSA6945268, KSA6945289, KSA6945301, KSA6945393, KSA6409216, KSA7120740, KSA7442810, KSA6569823, KSA6945117, KSA6945253, KSA6409251, KSA7120700, KSA6569813, KSA6945220, KSA6945234, KSA6409222, KSA6945176, KSA7442866, KSA5646324, KSA5646324, KSA6017496, KSA7013978, KSA6623212, KSA6623230, KSA6420033, KSA6649179, KSA6649182, KSA6649184, KSA6649212, KSA6649246, KSA6649251, KSA6649258, KSA6664008, KSA7727691, KSA7727701, KSA7732501, KSA7744955, KSA7744958, KSA7391403, KSA7391455, KSA7391492, KSA7304372, KSA7304414, KSA7732510, KSA7520478, KSA7391432, KSA7550176, KSA7716918, KSA7304379, KSA7162641, KSA7239672, KSA7239718, KSA7162590, KSA7442882, KSA7304395, KSA7304460, KSA6945374, KSA7013972, KSA6964879, KSA6964916, KSA6964948, KSA6866967, KSA7485749, KSA7391473, KSA6964893, KSA6623272, KSA6536527, KSA6536505, KSA6536521, KSA6536522, KSA6536523, KSA7509831, KSA7520485, KSA7550172, KSA7574778, KSA6536487, KSA6536492, KSA6536500, KSA7304456, KSA6536452, KSA6536458, KSA6664047, KSA7520469, KSA7520487, KSA7162576, KSA6536538, KSA6945390, KSA6664063, KSA6536444, KSA6536471, KSA6536474, KSA6536493, KSA7391437, KSA7096910.

Quantity Affected: 1249 units

Reason for Recall

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

Type: Voluntary: Firm initiated

Recall Initiated: 2026-04-24

Company