CLASS II ONGOING Device recall · Reported 3 Jun 2026 · FDA Enforcement Report
GE HealthCare Trade IN Carescape Telemetry Server Ark recalled
GE Medical Systems Information Technologies is recalling GE HealthCare Trade IN Carescape Telemetry Server Ark- - North America. The recall was initiated on 24 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2246-2026
- FDA event ID
- 98938
- Recalling firm
- GE Medical Systems Information Technologies, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Apr 2026
- FDA classified
- 28 May 2026
- Reported
- 3 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 24 Apr 2026 | Recall initiated by company | |
| 28 May 2026 | Classified by FDA | +34 days |
| 3 Jun 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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)
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
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.
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 98938More recalls from GE Medical Systems Information Technologies
All 18Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |