| | Class 2 Device Recall GE HealthCare |  |
| Date Initiated by Firm | April 24, 2026 |
| Date Posted | May 28, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2246-2026 |
| Recall Event ID |
98938 |
| 510(K)Number | K103142 |
| Product Classification |
Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
|
| Product | GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Code Information |
No UDI, Serial Number or Sales Order Number: KSA7536146, KSA7536158, KSA7536159, KSA7550156, KSA7550158, KSA7550159, KSA7667317, KSA7754389, KSA7769597, KSA7769610, KSA7769612, KSA7773420, KSA7773431, KSA7773440, KSA7120704, KSA7120767, KSA6964886, KSA6808842, KSA6808852, KSA6808866, KSA6808868, KSA6808881, KSA6808883, KSA6808912, KSA6808928, KSA6866974, KSA6664007, KSA6866963, KSA7120766, KSA7162586, KSA6623197, KSA6623216, KSA6623223, KSA6623226, KSA6623239, KSA6623248, KSA6623270, KSA6623278, KSA7391460, KSA6477094, KSA6477095, KSA6477135, KSA6477155, KSA6477159, KSA6477206, KSA6954245, KSA6954269, KSA6954276, KSA6954277, KSA6954284, KSA6954291, KSA6477096, KSA6477154, KSA7702196, KSA7702198, KSA7702199, KSA7702208, KSA7702222, KSA6623191, KSA6623194, KSA6623237, KSA6623251, KSA6623267, KSA6626626, KSA6626632, KSA6626639, KSA6626666, KSA6626670, KSA6626716, KSA6536442, KSA6536443, KSA6536454, KSA6536460, KSA6536469, KSA6536484, KSA6536485, KSA6536490, KSA6536496, KSA6536504, KSA6536526, KSA6536528, KSA6536532, KSA7120699, KSA7120728, KSA7120764, KSA7120773, KSA7162570, KSA7162593, KSA7162610, KSA7162622, KSA7162640, KSA6623198, KSA6623202, KSA6623232, KSA6623236, KSA6623275, KSA6623280, KSA6626622, KSA6626625, KSA6626635, KSA6626636, KSA6626648, KSA6626655, KSA6626659, KSA6626661, KSA6536520, KSA6536525, KSA7304431, KSA6866921, KSA6866926, KSA6866927, KSA6866983, KSA6808882, KSA6649195, KSA6649250, KSA7162575, KSA7162588, KSA7162608, KSA7162614, KSA7162656, KSA6899015, KSA6899022, KSA6808879, KSA5646278, KSA6017318, KSA6017321, KSA6017325, KSA6017333, KSA6017336, KSA6017352, KSA6017360, KSA6017361, KSA6017367, KSA6017368, KSA6017370, KSA6017371, KSA6017377, KSA6017378, KSA6017382, KSA6017383, KSA6017384, KSA6017385, KSA6017387, KSA6017388, KSA6017391, KSA6017404, KSA6017405, KSA6017406, KSA6017407, KSA6017409, KSA6017410, KSA6017416, KSA6017417, KSA6017424, KSA6017445, KSA6017450, KSA6017458, KSA6017471, KSA6017504, KSA6899026, KSA7676874, KSA7676878, KSA7676893, KSA7013925, KSA6808863, KSA6808864, KSA7304413, KSA7304437, KSA6945205, KSA6945208, KSA6945219, KSA6945223, KSA6945230, KSA6945236, KSA6945296, KSA6945314, KSA6945321, KSA6945340, KSA6945350, KSA6945353, KSA6945382, KSA6945387, KSA6899004, KSA6664048, KSA6664049, KSA6664054, KSA6664059, KSA6664075, KSA6664037, KSA6664045, KSA6664065, KSA6664069, KSA6623192, KSA6626641, KSA6626649, KSA6626687, KSA6626691, KSA6626701, KSA6626706, KSA6626707, KSA6626715, KSA6626718, KSA7120720, KSA7162574, KSA7162580, KSA7162632, KSA7162655, KSA6419987, KSA6419993, KSA6420030, KSA6420053, KSA6420080, KSA6420081, KSA6420082, KSA6420102, KSA6664002, KSA6664005, KSA6664036, KSA6664052, KSA6664057, KSA6664078, KSA6664090, KSA6664091, KSA6664006, KSA6866903, KSA6866924, KSA6866928, KSA6866933, KSA6866942, KSA6866977, KSA6866981, KSA6866987, KSA6866992, KSA6866996, KSA6899000, KSA6899060, KSA6945146, KSA6945185, KSA6945190, KSA6945191, KSA6945224, KSA6945250, KSA6945278, KSA6945294, KSA6945311, KSA6945391, KSA6945199, KSA6945204, KSA6945226, KSA6945244, KSA6945258, KSA6945302, KSA6945303, KSA6945319, KSA6945355, KSA6945358, KSA6945359, KSA6945384, KSA7013899, KSA7013902, KSA7013903, KSA7013905, KSA7013912, KSA7013914, KSA7013918, KSA7013921, KSA7013932, KSA7013940, KSA7013955, KSA7013956, KSA7013957, KSA7013963, KSA7013964, KSA7013973, KSA7013975, KSA7013986, KSA6569809, KSA6569821, KSA6569833, KSA6569840, KSA6569867, KSA6569890, KSA6569898, KSA6623189, KSA6623195, KSA6626637, KSA6626651, KSA6626690, KSA6626699, KSA6626713, KSA6626719, KSA6898999, KSA6899011, KSA6899013, KSA6899018, KSA6899021, KSA6899028, KSA6899029, KSA6899033, KSA6899034, KSA6899037, KSA6899051, KSA6899054, KSA6899059, KSA6899067, KSA6899070, KSA6899072, KSA6899074, KSA6899078, KSA6899080, KSA6899084, KSA6899085, KSA6899086, KSA6899092, KSA6899093, KSA6899097, KSA6945099, KSA6945100, KSA6945108, KSA6945113, KSA6945130, KSA6945140, KSA6945171, KSA6945175, KSA6945177, KSA6945183, KSA6945187, KSA6945189, KSA6945254, KSA6945262, KSA6945283, KSA6945288, KSA6945298, KSA6945310, KSA6945328, KSA6945331, KSA6945370, KSA6945377, KSA6945213, KSA6649214, KSA6649226, KSA6649261, KSA6649267, KSA6649272, KSA7120679, KSA7120683, KSA7120693, KSA7120725, KSA7120750, KSA7120754, KSA6689288, KSA6689302, KSA6689309, KSA6689313, KSA6689322, KSA6689364, KSA6689373, KSA6689375, KSA6689382, KSA7442815, KSA7676896, KSA7754382, KSA7754398, KSA7754402, KSA7769599, KSA7769600, KSA7769603, KSA7773423, KSA7773430, KSA7773436, KSA7773442, KSA7744947, KSA7744960, KSA7754384, KSA7754387, KSA7754395, KSA7769605, KSA7769607, KSA7769618, KSA7769622, KSA7773422, KSA7773428, KSA7773444, KSA7239656, KSA7239665, KSA7239668, KSA7239676, KSA7239677, KSA7239678, KSA7239683, KSA7239684, KSA7239686, KSA7239688, KSA7239694, KSA7239696, KSA7239697, KSA7239703, KSA7239704, KSA7239707, KSA7239708, KSA7239711, KSA7239712, KSA7239725, KSA7239728, KSA7239729, KSA7239736, KSA7239737, KSA7239741, KSA7239742, KSA7239743, KSA7239748, KSA6808841, KSA6808859, KSA6808902, KSA6808935, KSA6808936, KSA6623190, KSA6623209, KSA6623225, KSA6808870, KSA6808880, KSA7120744, KSA7120755, KSA6623204, KSA6623268, KSA6899005, KSA6899045, KSA6899050, KSA6899055, KSA6899089, KSA6623199, KSA6623214, KSA6626624, KSA6590128, KSA6590137, KSA6590143, KSA6590163, KSA6590170, KSA6590184, KSA6590210, KSA6590221, KSA6626663, KSA6626676, KSA6420092, KSA6420117, KSA6536467, KSA6536501, KSA6536510, KSA6536515, KSA6569806, KSA6569864, KSA6569903, KSA7724020, KSA7724027, KSA7724037, KSA7724040, KSA7727679, KSA7727686, KSA7727699, KSA7732509, KSA7732526, KSA7754383, KSA7773427, KSA6649211, KSA6649233, KSA6649263, KSA6569808, KSA6569839, KSA6569863, KSA6569871, KSA6569876, KSA6569888, KSA6808839, KSA6808853, KSA6808860, KSA6808893, KSA6808905, KSA6808919, KSA6808921, KSA6808924, KSA6808926, KSA6808938, KSA6409191, KSA6409209, KSA6409245, KSA6420002, KSA6420011, KSA6420108, KSA6477136, KSA6477153, KSA6477164, KSA6477184, KSA6477193, KSA6477196, KSA6477212, KSA6477225, KSA7550168, KSA7676876, KSA7724025, KSA7724045, KSA7727682, KSA7120701, KSA7120751, KSA7120713, KSA7120721, KSA7120731, KSA7120738, KSA7120741, KSA7120776, KSA7120777, KSA7013919, KSA7013934, KSA7013987, KSA6664013, KSA6664014, KSA6664016, KSA6664021, KSA6664083, KSA6664085, KSA6689285, KSA6689330, KSA6689353, KSA7391451, KSA7391479, KSA7442788, KSA7442812, KSA7442857, KSA7442859, KSA7442877, KSA7442879, KSA7442888, KSA7442895, KSA6866906, KSA6866919, KSA6866950, KSA6866970, KSA6866975, KSA6866976, KSA6866980, KSA6808847, KSA6808848, KSA6808849, KSA6808869, KSA6808888, KSA6808895, KSA6808914, KSA6808915, KSA6808918, KSA6808925, KSA7520462, KSA7520480, KSA6945229, KSA6623203, KSA6623229, KSA6623247, KSA6623264, KSA6626633, KSA6626634, KSA6626695, KSA6626717, KSA6623210, KSA6664055, KSA6664064, KSA7724021, KSA7724030, KSA7724033, KSA7732497, KSA7536149, KSA7120761, KSA7162595, KSA6945157, KSA6945235, KSA6945249, KSA6945275, KSA6945247, KSA6945290, KSA6945291, KSA6945327, KSA6945365, KSA7754377, KSA7769601, KSA7773419, KSA7773421, KSA7773429, KSA7773435, KSA6664003, KSA6866989, KSA7162566, KSA7162571, KSA7162585, KSA7162591, KSA7162594, KSA7162597, KSA7162607, KSA7162611, KSA7162615, KSA7162617, KSA7162620, KSA7162627, KSA7162633, KSA7162642, KSA7162643, KSA7162644, KSA7162647, KSA7162658, KSA7391429, KSA7391469, KSA7391472, KSA7096912, KSA7096925, KSA7096926, KSA7096929, KSA7096934, KSA7096936, KSA7096937, KSA7096938, KSA7096944, KSA7096948, KSA7096962, KSA7096973, KSA7096984, KSA7120708, KSA6945097, KSA6945109, KSA6945118, KSA6945128, KSA6945129, KSA6945132, KSA6945141, KSA6945181, KSA6017431, KSA6017433, KSA6017477, KSA6017495, KSA6017393, KSA6945394, KSA6899002, KSA6899019, KSA6899020, KSA6899030, KSA6899091, KSA6899048, KSA6899082, KSA6623185, KSA6623238, KSA6623261, KSA6649178, KSA6649227, KSA6649269, KSA6945147, KSA6945173, KSA6945277, KSA6945336, KSA6945120, KSA6945127, KSA6945148, KSA6945149, KSA6945156, KSA6945163, KSA6945168, KSA6945178, KSA6945179, KSA6945193, KSA6945260, KSA6945312, KSA6945341, KSA6945361, KSA6945395, KSA6964884, KSA6964914, KSA6964918, KSA6964930, KSA6964931, KSA6964941, KSA6626689, KSA7013890, KSA7013891, KSA7013893, KSA7013913, KSA7013923, KSA7013924, KSA7013942, KSA7013948, KSA7013954, KSA6945154, KSA6945215, KSA6945273, KSA6945300, KSA6945333, KSA6945352, KSA6945381, KSA6626630, KSA6626631, KSA6626657, KSA6626660, KSA6626665, KSA6626667, KSA6626672, KSA6626694, KSA6626697, KSA6626700, KSA6626709, KSA6964900, KSA6964911, KSA6964912, KSA6964922, KSA6964924, KSA6899044, KSA7239669, KSA7239670, KSA7239687, KSA7239698, KSA7239705, KSA7239714, KSA7239727, KSA7239730, KSA7239733, KSA7239746, KSA6569873, KSA6623228, KSA6623243, KSA6623266, KSA6623276, KSA6626640, KSA6626642, KSA6626643, KSA6626650, KSA6626653, KSA6626673, KSA6626675, KSA6626678, KSA6626711, KSA7096993, KSA7120702, KSA7120703, KSA7120705, KSA7120710, KSA7120759, KSA7120769, KSA7162573, KSA7162599, KSA7162601, KSA7162635, KSA7162651, KSA7162657, KSA6945165, KSA6945315, KSA6477102, KSA6477115, KSA6477145, KSA6477150, KSA6945209, KSA6945212, KSA6945232, KSA6945271, KSA6945276, KSA6409175, KSA6409178, KSA6409192, KSA6409193, KSA6409204, KSA6409207, KSA6409210, KSA6409212, KSA6409226, KSA6409232, KSA6409236, KSA7162604, KSA7162645, KSA7744936, KSA7744945, KSA7744948, KSA7744954, KSA7744962, KSA7744963, KSA7754380, KSA7754388, KSA7754394, KSA7754403, KSA7754406, KSA7769595, KSA7769604, KSA7769616, KSA7769620, KSA7773418, KSA7773426, KSA7773437, KSA7773441, KSA7442825, KSA7442839, KSA7676899, KSA7727681, KSA7744940, KSA7744942, KSA7744949, KSA7744950, KSA7754378, KSA7754379, KSA7754381, KSA7754392, KSA7754393, KSA7754397, KSA7754399, KSA7754404, KSA7769594, KSA7769611, KSA7769615, KSA7769619, KSA7773425, KSA7773432, KSA7773438, KSA6623255, KSA6626621, KSA6626629, KSA6626664, KSA6626714, KSA7442808, KSA6899036, KSA7724028, KSA7239735, KSA7013974, KSA6623222, KSA6626644, KSA6626692, KSA7120717, KSA7120745, KSA7162629, KSA7162648, KSA7120687, KSA7162567, KSA7162598, KSA7239659, KSA7239660, KSA7239671, KSA7239680, KSA7239715, KSA7239717, KSA7239720, KSA7239731, KSA7239732, KSA7304420, KSA6945182, KSA6945211, KSA7120718, KSA7013941, KSA7574789, KSA6477112, KSA6477120, KSA6477152, KSA6477179, KSA6477194, KSA6866946, KSA6866969, KSA6477157, KSA6477176, KSA6477185, KSA6477192, KSA6477228, KSA6899008, KSA6899056, KSA6945266, KSA6945323, KSA7013889, KSA7013898, KSA7013904, KSA7013908, KSA7013909, KSA7013911, KSA7013920, KSA7013922, KSA7013927, KSA7013929, KSA7013930, KSA7013931, KSA7013936, KSA7013945, KSA7013951, KSA7013960, KSA7013961, KSA7013965, KSA7013966, KSA7013970, KSA7013981, KSA7013988, KSA6477127, KSA6477174, KSA6477226, KSA6477245, KSA6477252, KSA6569835, KSA6664030, KSA6664033, KSA6664086, KSA6866930, KSA6866949, KSA6866982, KSA6477200, KSA6477117, KSA6477146, KSA6477190, KSA6477229, KSA6536456, KSA6945124, KSA6945139, KSA6945180, KSA6945216, KSA6945263, KSA6945284, KSA6017386, KSA6017421, KSA6017437, KSA6017510, KSA6945227, KSA6945242, KSA6945256, KSA6945264, KSA6945299, KSA6945308, KSA6945338, KSA6536461, KSA6536464, KSA6536468, KSA6536475, KSA6536477, KSA6536483, KSA6536491, KSA7162564, KSA7162578, KSA7162636, KSA7162652, KSA6664017, KSA6664018, KSA6866905, KSA6945119, KSA6945143, KSA6945150, KSA6945164, KSA6945239, KSA6945243, KSA6945282, KSA6945316, KSA6945354, KSA6945373, KSA6623193, KSA6623196, KSA6623211, KSA6623213, KSA6623215, KSA6623217, KSA6623224, KSA6623227, KSA6623252, KSA6623254, KSA6623257, KSA6623271, KSA6626620, KSA6626647, KSA6626669, KSA5646290, KSA6477220, KSA6649208, KSA6866960, KSA6808916, KSA6536519, KSA6409201, KSA6945162, KSA6649220, KSA6866902, KSA6866916, KSA6866937, KSA6649202, KSA6649249, KSA6649262, KSA6623283, KSA6590123, KSA6590124, KSA6590126, KSA6590138, KSA6590139, KSA6590140, KSA6590141, KSA6590161, KSA6590172, KSA6590174, KSA6590177, KSA6590188, KSA6590191, KSA6590197, KSA6590199, KSA6590208, KSA6590211, KSA6623207, KSA6623233, KSA6623256, KSA6623260, KSA6623263, KSA6623277, KSA6623279, KSA6623281, KSA6623284, KSA6664092, KSA6808871, KSA6808890, KSA6808894, KSA6808903, KSA6808907, KSA6808917, KSA6409157, KSA6409237, KSA6409247, KSA6477109, KSA6477114, KSA6477144, KSA6477151, KSA6477181, KSA6477197, KSA6477231, KSA6477240, KSA6477250, KSA6536529, KSA7550151, KSA7550173, KSA7574767, KSA7574784, KSA7590252, KSA7590258, KSA7590260, KSA7590263, KSA7590266, KSA7667307, KSA7667318, KSA7667321, KSA7667323, KSA7667332, KSA6664088, KSA7590242, KSA7590264, KSA7667311, KSA7667325, KSA7667326, KSA7667328, KSA7667333, KSA7667334, KSA7667306, KSA7667314, KSA7667315, KSA7667319, KSA7667327, KSA7667335, KSA6945159, KSA6808899, KSA7442791, KSA7442841, KSA7667309, KSA7667313, KSA7667329, KSA7676872, KSA7676873, KSA7676880, KSA7676891, KSA7676892, KSA7676894, KSA7676897, KSA7676898, KSA7676900, KSA7702195, KSA7702197, KSA7702202, KSA7702204, KSA7702205, KSA7702206, KSA7702207, KSA7702209, KSA7702211, KSA7702212, KSA7702213, KSA7702215, KSA7702216, KSA7702217, KSA7702218, KSA7702221, KSA6536441, KSA7574786, KSA7590241, KSA7590269, KSA7590246, KSA7590247, KSA7590267, KSA7667308, KSA7667312, KSA7667316, KSA7667322, KSA7676875, KSA7676877, KSA7676879, KSA7676881, KSA7676882, KSA7676884, KSA7676885, KSA7676887, KSA7676890, KSA7676895, KSA7702194, KSA7702200, KSA7702201, KSA7702203, KSA7702210, KSA7702214, KSA7702219, KSA7702220, KSA7702223, KSA7590249, KSA7590251, KSA7590257, KSA7590262, KSA7667310, KSA7667324, KSA7667330, KSA6623231, KSA6626671, KSA6626684, KSA6626703, KSA6664038, KSA6866912, KSA7120682, KSA7120732, KSA7120733, KSA7120749, KSA7120756, KSA7120774, KSA7162628, KSA7550171, KSA7574788, KSA6945255, KSA7520488, KSA6964960, KSA6899039, KSA6954214, KSA6954225, KSA6954228, KSA6954231, KSA6954233, KSA6954238, KSA6954239, KSA6954248, KSA6954258, KSA6954259, KSA6954262, KSA6954264, KSA6954266, KSA6954285, KSA6954289, KSA6954300, KSA6954304, KSA6954309, KSA6945362, KSA6649242, KSA6536463, KSA7727680, KSA7732508, KSA7732519, KSA6689341, KSA6689348, KSA6689362, KSA6689367, KSA6649189, KSA6649222, KSA6649224, KSA6649236, KSA6649237, KSA6649243, KSA6649253, KSA6649259, KSA6649264, KSA6649265, KSA7442807, KSA7727685, KSA7732514, KSA6689298, KSA6689308, KSA6689336, KSA6689340, KSA6689345, KSA6689357, KSA7520470, KSA7520472, KSA7536139, KSA7536145, KSA7536152, KSA7536154, KSA7536163, KSA7536165, KSA7536166, KSA7536168, KSA7442783, KSA7442795, KSA7442803, KSA7442806, KSA7442809, KSA7442820, KSA7442824, KSA7442826, KSA7442831, KSA7442832, KSA7442833, KSA7442835, KSA7442842, KSA7442860, KSA7442864, KSA7442875, KSA7442890, KSA6649229, KSA6569831, KSA6569893, KSA6569895, KSA6569899, KSA6536447, KSA6536451, KSA6536455, KSA6536462, KSA6536476, KSA6536478, KSA6536489, KSA6536498, KSA6536506, KSA6536508, KSA6536509, KSA6536513, KSA6536518, KSA6536533, KSA6536540, KSA6623186, KSA6623240, KSA6623269, KSA6649201, KSA6649215, KSA6649235, KSA6649260, KSA6649270, KSA6866901, KSA6664023, KSA7120689, KSA7120757, KSA6626627, KSA5646249, KSA5646255, KSA5646273, KSA5646279, KSA7391402, KSA7391434, KSA7391441, KSA7391457, KSA7391465, KSA7391474, KSA7391484, KSA7391488, KSA7391494, KSA7391497, KSA7391500, KSA7442776, KSA7442785, KSA7442793, KSA7442794, KSA7442796, KSA7442802, KSA7442805, KSA7442811, KSA7442823, KSA7442834, KSA7442844, KSA7442846, KSA7442855, KSA7442868, KSA7442869, KSA7442872, KSA7442884, KSA7442885, KSA7442889, KSA7442893, KSA7509842, KSA6945152, KSA7485765, KSA6649176, KSA6649180, KSA6649192, KSA6649194, KSA6649199, KSA6649200, KSA6649207, KSA6649248, KSA6866953, KSA6866958, KSA7120685, KSA7120697, KSA7120709, KSA7120711, KSA7120714, KSA7120726, KSA7120753, KSA7120765, KSA7120775, KSA6649174, KSA6649181, KSA6649187, KSA6649188, KSA6649190, KSA6649209, KSA6649210, KSA6649213, KSA6649231, KSA6649238, KSA6649239, KSA6649240, KSA6649245, KSA6649254, KSA6649271, KSA6623206, KSA6623219, KSA6623235, KSA6623245, KSA6945111, KSA6945135, KSA6945155, KSA6945186, KSA6945198, KSA6945339, KSA6945369, KSA6945380, KSA6899035, KSA7391416, KSA7391476, KSA7485740, KSA7590243, KSA6664015, KSA6664020, KSA6664027, KSA7239662, KSA7239666, KSA7239692, KSA7239719, KSA7239723, KSA7239724, KSA7239726, KSA7304375, KSA7304382, KSA7304401, KSA7304412, KSA7304419, KSA7304423, KSA7304429, KSA7304433, KSA7304436, KSA7304439, KSA7304446, KSA7304458, KSA7667320, KSA7676888, KSA7724022, KSA7724024, KSA7727684, KSA7727689, KSA7727690, KSA7727692, KSA7727695, KSA7727696, KSA7727700, KSA7727702, KSA7732506, KSA7732515, KSA7732520, KSA7732521, KSA7732522, KSA6954220, KSA6954230, KSA6954241, KSA6954274, KSA6954281, KSA6954287, KSA6954302, KSA7120680, KSA7120681, KSA7120686, KSA7120690, KSA7120706, KSA7120712, KSA7120722, KSA7120727, KSA7120729, KSA7120746, KSA7120760, KSA7120763, KSA7120772, KSA7096906, KSA7096913, KSA7096954, KSA7096991, KSA7096992, KSA6954270, KSA7162606, KSA7162646, KSA7162649, KSA7239650, KSA7239651, KSA7239658, KSA7239661, KSA7239663, KSA7239664, KSA7239681, KSA7239685, KSA7239745, KSA7304362, KSA7304399, KSA7304402, KSA7304408, KSA7304428, KSA7304445, KSA7485736, KSA7485739, KSA7485747, KSA7485764, KSA7495810, KSA7495818, KSA7495822, KSA7509828, KSA7509829, KSA7509832, KSA7509833, KSA7509835, KSA7509838, KSA7509840, KSA7509844, KSA7509847, KSA7509849, KSA7509854, KSA6569828, KSA6569855, KSA6569859, KSA6569878, KSA6569885, KSA6569902, KSA6409160, KSA6409166, KSA6409168, KSA6409182, KSA6409184, KSA6409185, KSA6409189, KSA6409190, KSA6409199, KSA6409200, KSA6409214, KSA6409218, KSA6409224, KSA6409229, KSA6409243, KSA6409250, KSA6409252, KSA6409254, KSA6569827, KSA6569832, KSA6569858, KSA6569869, KSA6409158, KSA6477103, KSA6477106, KSA6477107, KSA6477108, KSA6477119, KSA6477122, KSA6477125, KSA6477129, KSA6477133, KSA6477137, KSA6477140, KSA6477147, KSA6477149, KSA6477156, KSA6477167, KSA6477172, KSA6477180, KSA6477188, KSA6477189, KSA6477195, KSA6477202, KSA6477204, KSA6477211, KSA6477213, KSA6477215, KSA6477216, KSA6477217, KSA6477218, KSA6477230, KSA6477232, KSA6477233, KSA6477236, KSA6477238, KSA6477239, KSA6477241, KSA6477242, KSA6477243, KSA6477247, KSA6477249, KSA6536446, KSA6536448, KSA6536450, KSA6536453, KSA6536457, KSA6536465, KSA6536466, KSA6536473, KSA6536479, KSA6536481, KSA6536486, KSA6536495, KSA6536497, KSA6536499, KSA6536507, KSA6536539, KSA6569820, KSA6569824, KSA6569834, KSA6569836, KSA6569843, KSA6569857, KSA6569865, KSA6569870, KSA6569886, KSA6569892, KSA6590179, KSA7239693, KSA6419983, KSA6419992, KSA6419995, KSA6420013, KSA6420014, KSA6420021, KSA6420029, KSA6420032, KSA6420041, KSA6420044, KSA6420045, KSA6420051, KSA6420063, KSA6420070, KSA6420071, KSA6420079, KSA6420084, KSA6420095, KSA6420107, KSA6420109, KSA6420111, KSA6420119, KSA6420120, KSA6419986, KSA6420010, KSA6420025, KSA6420035, KSA6420042, KSA6420043, KSA6420046, KSA6420048, KSA6420050, KSA6420056, KSA6420060, KSA6420065, KSA6420072, KSA6420085, KSA6420090, KSA6420097, KSA6420098, KSA6420101, KSA6420118, KSA6477166, KSA6477201, KSA6419988, KSA6420005, KSA6420008, KSA6420009, KSA6420015, KSA6420016, KSA6420017, KSA6420018, KSA6420031, KSA6420034, KSA6420036, KSA6420037, KSA6420040, KSA6420047, KSA6420052, KSA6420055, KSA6420059, KSA6420062, KSA6420068, KSA6420069, KSA6420073, KSA6420086, KSA6420087, KSA6420093, KSA6420099, KSA6420105, KSA6420112, KSA6420113, KSA6420114, KSA6420116, KSA6420121, KSA6420122, KSA6477099, KSA6477100, KSA6477118, KSA6477123, KSA6477130, KSA6477132, KSA6477134, KSA6477138, KSA6477141, KSA6477160, KSA6477171, KSA6477173, KSA6477198, KSA6477209, KSA6477219, KSA6477221, KSA6477223, KSA6477224, KSA6477235, KSA6664073, KSA6419985, KSA6419989, KSA7536151, KSA7550153, KSA7550154, KSA7550165, KSA7550167, KSA7550175, KSA6569826, KSA6569841, KSA6569842, KSA6569845, KSA6569860, KSA6569882, KSA6569889, KSA6569894, KSA6419984, KSA6419994, KSA6419996, KSA6420004, KSA6420007, KSA6420038, KSA6420061, KSA6420067, KSA6420075, KSA6420076, KSA6420104, KSA6569817, KSA6569822, KSA6569825, KSA6569830, KSA6569844, KSA6569848, KSA6569849, KSA6569852, KSA6569887, KSA6569901, KSA6623244, KSA7536143, KSA7536147, KSA7536150, KSA7536153, KSA7536161, KSA7536164, KSA7536167, KSA7391420, KSA7391433, KSA7391438, KSA7391442, KSA7391445, KSA7391466, KSA6866990, KSA7590245, KSA7550149, KSA7550150, KSA7550174, KSA7574769, KSA7574773, KSA7574775, KSA7574779, KSA7574781, KSA7574785, KSA7574790, KSA7590240, KSA7590256, KSA7590259, KSA6866900, KSA6866920, KSA6866929, KSA6866931, KSA6866945, KSA6866956, KSA6866957, KSA6866962, KSA6866973, KSA6866985, KSA6866995, KSA6866997, KSA6866999, KSA6945102, KSA6945107, KSA6945121, KSA6945160, KSA6945214, KSA6945225, KSA6945228, KSA6945238, KSA6945307, KSA6945326, KSA6945349, KSA6945360, KSA6945375, KSA6964880, KSA6964895, KSA6964896, KSA6964901, KSA6964910, KSA6964926, KSA6964932, KSA6964933, KSA6964953, KSA6964964, KSA6964966, KSA6689327, KSA6689344, KSA6689352, KSA6689363, KSA6689383, KSA6689300, KSA6689305, KSA6689306, KSA6689347, KSA6689355, KSA6689371, KSA6590142, KSA6590145, KSA6590152, KSA6590168, KSA6590186, KSA6590195, KSA6590206, KSA6590209, KSA5646264, KSA6017314, KSA6017324, KSA6017394, KSA6017398, KSA6017403, KSA6017408, KSA6017435, KSA6017508, KSA6689293, KSA6689323, KSA6689331, KSA6689346, KSA6689358, KSA6689360, KSA6689381, KSA6808867, KSA6808840, KSA6808845, KSA6808856, KSA6808858, KSA6808862, KSA6808865, KSA6808872, KSA6808875, KSA6808877, KSA6808885, KSA6808886, KSA6808889, KSA6808901, KSA6808906, KSA6808908, KSA6808911, KSA6808922, KSA6808929, KSA6808930, KSA7495817, KSA7520477, KSA7550177, KSA7120707, KSA7120762, KSA6689314, KSA6689350, KSA6866911, KSA6866914, KSA6866915, KSA6866918, KSA6866936, KSA6866959, KSA6866972, KSA6866978, KSA7442845, KSA7485737, KSA7485748, KSA7485760, KSA7485762, KSA6649177, KSA6649185, KSA6649232, KSA7574766, KSA7574780, KSA7724038, KSA7724039, KSA7485756, KSA7495832, KSA6649204, KSA6649223, KSA6945188, KSA6945217, KSA6945246, KSA6945251, KSA6945257, KSA6945305, KSA6945317, KSA6945322, KSA6945329, KSA6945343, KSA6945344, KSA6945351, KSA6945366, KSA6945368, KSA6945376, KSA6945378, KSA6945383, KSA6945392, KSA6945396, KSA7727674, KSA7769598, KSA7676883, KSA6689289, KSA6689294, KSA6689301, KSA6689303, KSA6689319, KSA6689320, KSA6689324, KSA6689325, KSA6689334, KSA6689335, KSA6689337, KSA6689376, KSA7520483, KSA6663994, KSA6663997, KSA6663998, KSA6664019, KSA6664022, KSA7096907, KSA7096917, KSA7096921, KSA7096951, KSA7096952, KSA7096967, KSA7096978, KSA7096988, KSA7096996, KSA6569805, KSA6569810, KSA6569818, KSA6569829, KSA6569837, KSA6569847, KSA6569850, KSA6569851, KSA6569861, KSA6569881, KSA6689286, KSA7096914, KSA7096919, KSA7096920, KSA7096930, KSA7096949, KSA7096956, KSA7096969, KSA7096982, KSA7096987, KSA7096990, KSA7096997, KSA6964913, KSA6964920, KSA6964938, KSA7391427, KSA7442849, KSA7536144, KSA7096902, KSA7096909, KSA7096911, KSA7096915, KSA7096916, KSA7096923, KSA7096933, KSA7096939, KSA7096960, KSA7096965, KSA7096966, KSA7096974, KSA7096975, KSA7096981, KSA7096983, KSA7096989, KSA7096995, KSA6964890, KSA6945133, KSA6964878, KSA6964885, KSA6964887, KSA6964894, KSA6964936, KSA6964969, KSA7120768, KSA7162639, KSA6899003, KSA7304377, KSA7304397, KSA7304400, KSA7391409, KSA7391411, KSA7391431, KSA7391444, KSA7391454, KSA7391458, KSA7391459, KSA7391467, KSA7391470, KSA7391485, KSA6664082, KSA6945166, KSA6945388, KSA6964875, KSA6964882, KSA6964921, KSA6964925, KSA6964955, KSA7120715, KSA7239652, KSA7239667, KSA7239674, KSA7239675, KSA7239679, KSA7239682, KSA7239691, KSA7239695, KSA7239699, KSA7239700, KSA7239701, KSA7239716, KSA7239721, KSA7239722, KSA7239739, KSA7239744, KSA7239749, KSA7304369, KSA7304374, KSA7304376, KSA7304384, KSA7304385, KSA7304404, KSA7304405, KSA7304407, KSA7304410, KSA7304417, KSA7304438, KSA7304442, KSA7304451, KSA6964906, KSA6964907, KSA6964923, KSA6964927, KSA6964928, KSA6964934, KSA6964937, KSA6964945, KSA6964956, KSA6964963, KSA7676889, KSA6866908, KSA6866944, KSA6866979, KSA6898998, KSA6899001, KSA6899006, KSA6899007, KSA6899009, KSA6899016, KSA6899025, KSA6899027, KSA6899031, KSA6899032, KSA6899046, KSA6899047, KSA6899052, KSA6899053, KSA6899057, KSA6899058, KSA6899061, KSA6899062, KSA6899064, KSA6899066, KSA6899071, KSA6899075, KSA6899077, KSA6899079, KSA6899081, KSA6899087, KSA6899090, KSA6899094, KSA6899095, KSA6899096, KSA7120692, KSA7120716, KSA7120739, KSA7120748, KSA7120691, KSA7120730, KSA7120734, KSA7120736, KSA7120742, KSA7120747, KSA7162568, KSA7162569, KSA7162579, KSA6964883, KSA6689379, KSA7120684, KSA7120698, KSA7162613, KSA7162654, KSA7162659, KSA6590127, KSA6590129, KSA6590130, KSA6590149, KSA6590151, KSA6590155, KSA6590173, KSA6590181, KSA6590185, KSA6590201, KSA6590202, KSA6590212, KSA6590214, KSA6590215, KSA6590222, KSA6536449, KSA7013928, KSA7013944, KSA7013958, KSA7013979, KSA7724018, KSA7727683, KSA7727693, KSA7727694, KSA7727697, KSA7727698, KSA7732498, KSA7732502, KSA7732504, KSA7732505, KSA7732511, KSA7732517, KSA7732518, KSA7732523, KSA7732524, KSA6689290, KSA6689304, KSA6689318, KSA6689354, KSA6689361, KSA6689368, KSA6689372, KSA6689377, KSA6623234, KSA6626628, KSA6626638, KSA6626683, KSA6626688, KSA6590132, KSA6590134, KSA6590135, KSA6590144, KSA6590146, KSA6590147, KSA6590156, KSA6590157, KSA6590158, KSA6590159, KSA6590160, KSA6590166, KSA6590169, KSA6590175, KSA6590176, KSA6590187, KSA6590192, KSA6590194, KSA6590198, KSA6590200, KSA6590203, KSA6590204, KSA6590205, KSA6590207, KSA6590213, KSA6590218, KSA6590219, KSA6420058, KSA6569807, KSA6569815, KSA6569819, KSA6569854, KSA6569872, KSA6569874, KSA6569877, KSA6569897, KSA6536470, KSA6536480, KSA6536482, KSA6536531, KSA6536536, KSA6623200, KSA6623201, KSA6623218, KSA6626652, KSA6626656, KSA6626662, KSA6626674, KSA6626677, KSA6626680, KSA6626693, KSA6420000, KSA6420006, KSA6420027, KSA6420049, KSA6420054, KSA6420066, KSA6420094, KSA6420100, KSA6866910, KSA6623242, KSA6945101, KSA6945196, KSA7485742, KSA7485746, KSA7485751, KSA7509836, KSA7520461, KSA7520464, KSA7520465, KSA7520479, KSA7520484, KSA7536140, KSA7536141, KSA7536148, KSA7536155, KSA7536156, KSA7536157, KSA7536162, KSA7550155, KSA6945114, KSA6945116, KSA6945123, KSA6945125, KSA6945126, KSA6945131, KSA6945134, KSA6945145, KSA6945346, KSA6945357, KSA6945363, KSA6945385, KSA7724031, KSA7727678, KSA7536160, KSA6536512, KSA6536517, KSA6536530, KSA6664072, KSA6649193, KSA6649196, KSA6649197, KSA6649198, KSA6649216, KSA6649218, KSA6649219, KSA6649225, KSA6649228, KSA6649230, KSA6649234, KSA6649252, KSA6649256, KSA6649273, KSA6664029, KSA6664031, KSA6664039, KSA6664041, KSA6664053, KSA6664071, KSA6664077, KSA6664079, KSA6664081, KSA6664084, KSA6664087, KSA6419999, KSA6808844, KSA6808854, KSA6808855, KSA6808913, KSA6808927, KSA6808934, KSA6649191, KSA6954215, KSA6954223, KSA6954226, KSA6954232, KSA6954237, KSA6954242, KSA6954244, KSA6954247, KSA6954251, KSA6954253, KSA6954257, KSA6954260, KSA6954261, KSA6954268, KSA6954273, KSA6954280, KSA7162563, KSA6964940, KSA6945265, KSA6954222, KSA6954229, KSA6954249, KSA6954252, KSA6954282, KSA6954293, KSA6954294, KSA6954298, KSA6954299, KSA6954305, KSA7120719, KSA7391405, KSA7391417, KSA7391421, KSA7391423, KSA7391425, KSA7391426, KSA7391448, KSA7391471, KSA7391487, KSA7391499, KSA6664050, KSA6664068, KSA7013971, KSA7013982, KSA7013983, KSA7724034, KSA6409162, KSA6409170, KSA6409174, KSA6409194, KSA6409196, KSA6409239, KSA6409246, KSA6409248, KSA7485741, KSA7442798, KSA7442840, KSA7442865, KSA7442894, KSA6477101, KSA6477105, KSA6477110, KSA6477121, KSA6477131, KSA6477158, KSA6477162, KSA6477165, KSA6477169, KSA6477170, KSA6477178, KSA6477182, KSA6477186, KSA6477187, KSA6477203, KSA6477207, KSA6477214, KSA6477227, KSA6477244, KSA6477246, KSA6477251, KSA6477253, KSA6569862, KSA6569883, KSA6569884, KSA6649186, KSA6649217, KSA6945318, KSA6590153, KSA6945112, KSA6945151, KSA6945222, KSA6945252, KSA6945274, KSA6945279, KSA6945335, KSA6945389, KSA6017323, KSA6017357, KSA6017436, KSA6017457, KSA6017464, KSA6017466, KSA6017472, KSA6017473, KSA6017476, KSA6017480, KSA6017486, KSA6017488, KSA6017489, KSA6017492, KSA6017501, KSA6017506, KSA6945106, KSA6945269, KSA6945287, KSA7744935, KSA7744937, KSA7744938, KSA7744941, KSA7744943, KSA7744946, KSA7744951, KSA7744952, KSA7744959, KSA7744964, KSA7239657, KSA7239653, KSA7239689, KSA6945248, KSA7727677, KSA6945202, KSA6945210, KSA6945231, KSA6945241, KSA6945245, KSA6945281, KSA6945306, KSA6663996, KSA6664004, KSA6664009, KSA6664010, KSA6664012, KSA6664028, KSA6664032, KSA6664035, KSA6664056, KSA6664061, KSA6664080, KSA6664011, KSA6664034. |
| FEI Number |
3001570235
|
Recalling Firm/ Manufacturer |
GE Medical Systems Information Technologies Inc 3114 N Grandview Blvd Waukesha WI 53188-1615
|
| For Additional Information Contact | GE HealthCare Service 800-437-1171 |
Manufacturer 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). |
FDA Determined Cause 2 | 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 in Commerce | 2366 units |
| Distribution | Worldwide distribution. |
| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = MHX
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