GE Medical Systems Information Technologies Inc: 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)

Recall number

Z-2245-2026

Recalling firm

GE Medical Systems Information Technologies Inc

Product

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)

Status

Open, Classified

Initiated

2026-04-24

Posted

2026-05-28

Terminated

not on file

Reason

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).

Root cause

Software design

Action

GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 4/24/2026 by letter using a traceable means. The notice explained the the safety issue pertaining to the persistent NO COMM or OFF NETWORK condition, and provided instructions for the safe use of the device should either issue arise. "Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue to use your ApexPro CTS with Central Station for telemetry only or combination monitoring unless you observe a persistent (more than a few seconds) NO COMM or OFF NETWORK notification. If you do observe a persistent NO COMM or OFF NETWORK notification, follow the instructions below. 1. Use alternative bedside patient monitoring to ensure continuous clinical surveillance until the NO COMM or OFF NETWORK condition is resolved by GE HealthCare. NOTE: If you are using combination monitoring, it is recommended to switch ECG monitoring to the bedside monitor. 2. Immediately notify your Facility s Biomedical Engineering, IT or Service Department and contact GE HealthCare Service. 3. Verify monitoring is restored at the Central Station(s) and/or bedside monitor(s). Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please post this notification by your Central Station(s). Please retain this document for your records." "GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Quantity

1249 units

Distribution

Worldwide distribution.

Lot, serial or model codes

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.

510(k) numbers

["K103142"]

PMA numbers

not on file

Product code

MHX

Firm FEI

3001570235

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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