--- title: "1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: ... — FDA record Z-0435-2026 | Is It on Recall" description: "GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement i" url: https://isitonrecall.com/recall/fda-device-z-0435-2026-1202-flex-focus-ultrasound-system-cart-models-ua1214-and-ua1814-used-with-flex-focus-200-flex-focus/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Foc... — FDA record Z-0435-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Oct 9, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic - **Reason**: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions. - **Classification**: Class II - **Recalling firm**: B-K Medical A/S - **Quantity**: 4426 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0435-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0435-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 1) GTIN 05704916001056, Serial Numbers: 4005090, 4005710, 4002577, 4001807, 4002211, 4004085, 4006424, 4004772, 4101695, 4006420, 4100894, 4003775, 4004724, 4000321, 4004803, 4101755, 4101757, 4004635, 4004641, 4003082, 4004188, 4004448, 4100213, 4101302, 4000466, 4002982, 4006605, 4004941, 4100713, 4003569, 4003390, 4006608, 4101728, 4101906, 4005490, 4100128, 4001502, 4005922, 4006602, 4101724, 4005913, 4101394, 4001066, 4005230, 4000771, 4001536, 4003417, 4004297, 4102893, 4103104, 4003275, 4004575, 4100395, 4004038, 4004201, 4006350, 4100035, 4006123, 4100092, 4005380, 4005961, 4000460, 4005679, 4001915, 4005334, 4005346, 4001503, 4001694, 4003141, 4003626, 4004412, 4004431, 4005447, 4100060, 4005190, 4002880, 4101872, 4004088, 4004339, 4102033, 4005920, 4101823, 4007095, 4005228, 4004443, 4101990, 4002023, 4002190, 4005993, 4004423, 4101552, 4006362, 4001532, 4100603, 4005243, 4006010, 4006113, 4006114, 4006117, 4006126, 4101988, 4006950, 4006815, 4005778, 4101506, 4102036, 1909816, 4101756, 4002916, 4005906, 4101758, 4003821, 4005258, 4003139, 4101504, 4003884, 4005352, 4005769, 4005771, 4101555, 4003052, 4100463, 4007074, 4100140, 4002947, 4001137, 4006812, 4001266, 4005650, 4101956, 4003731, 4006409, 4004632, 4005337, 4100943, 4102414, 1910262, 4000166, 4101225, 4003164, 4001683, 4005372, 1910167, 4001651, 4005649, 4002186, 4101725, 4101991, 4000074, 4000845, 4001946, 4004994, 4007036, 4007038, 4007039, 4007040, 4007042, 4007053, 4100040, 4100057, 4100068, 4100069, 4100070, 4100127, 4100194, 4100819, 4100822, 4100839, 4100870, 4100873, 4101526, 4101554, 4101632, 4101646, 4101677, 4101803, 4101828, 4101836, 4101863, 4101867, 4101983, 4102012, 4102015, 4102105, 4005729, 4102419, 4100133, 4005972, 4102328, 4102417, 4004344, 1910010, 4004855, 4006810, 4003561, 4005461, 4101634, 4100330, 4006425, 4101099, 4004192, 4005257, 4006943, 1907405, 1907367, 4002579, 4100225, 4101206, 4005868, 4005872, 4102993, 4101253, 4001126, 4005184, 4003763, 4001414, 4001692, 4001702, 4005128, 4101117, 4101958, 4101538, 4005496, 4001534, 4001656, 4101349, 4001996, 4002470, 4005442, 4005928, 4002588, 4005969, 4001421, 4004649, 4101537, 4006418, 4006809, 4002276, 4100887, 4001389, 4100995, 4101180, 4102121, 4003545, 4006998, 4102575, 4001707, 4004885, 4006796, 4006404, 4102416, 4006997, 4006941, 4101826, 4101114, 4004766, 4002422, 4004696, 4007085, 4003532, 4101804, 4005735, 4003770, 4101606, 4003229, 4001132, 4001133, 4001136, 4001448, 4003059, 4003885, 4004343, 4004567, 4005936, 4100744, 4101601, 4003000, 4002272, 4002467, 4005797, 4003682, 4004789, 4001499, 4004006, 4004426, 4005485, 4005487, 4000782, 4003768, 4101249, 4101304, 1907823, 1908864, 4003525, 4003539, 4004671, 4101400, 4101401, 4101403, 4101407, 4003391, 4101228, 4005945, 4005793, 4101722, 4005680, 4002448, 4000145, 4000889, 4000421, 4002995, 4002839, 4004413, 4001680, 4003542, 4005977, 4005341, 4006624, 4006879, 4005169, 4100533, 4100600, 4005504, 4100679, 4005998, 4003772, 4005168, 4005383, 4101404, 4101955, 4005373, 4100096, 4101156, 4005967, 4101245, 4100480, 4004232, 4006924, 4101132, 4005773, 4007097, 4100761, 4101398, 4005351, 4004628, 4004658, 4004999, 4005335, 4101247, 4004889, 4005444, 4004725, 4007049, 4005088, 4005344, 4003056, 4100411, 4004042, 4100062, 4100454, 4003162, 4004226, 4000966, 4100390, 4100210, 4003415, 4003457, 4003879, 4004385, 4005935, 4007007, 4006486, 4004467, 4005384, 4101270, 4004875, 4004010, 4101419, 4102169, 4002921, 4002948, 4004436, 1910149, 4006308, 4000841, 4001531, 4003528, 4003198, 4003625, 4005436, 4003160, 4003684, 4006801, 4100086, 4101396, 4004828, 4006874, 4004422, 4000994, 4006329, 4006987, 4005249, 4100550, 4005369, 4005092, 4005229, 4005642, 4005879, 4101361, 4002277, 4003054, 4004618, 4005724, 4005852, 4005934, 4003225, 4006932, 4006988, 4001381, 4001415, 4005185, 4000136, 4000327, 4000461, 4000464, 4000474, 4004698, 4001686, 4004231, 4001422, 4005507, 4101183, 4101764, 4101961, 4101967, 4002352, 4005751, 4002069, 4002625, 4101701, 4100232, 4005086, 4006333, 4004656, 4005743, 4000871, 4000882, 4004598, 4101687, 4001690, 4001992, 4002020, 4002021, 4002078, 4005374, 4100546, 4004388, 4007072, 4005027, 4001805, 4002729, 4003140, 4001418, 4003017, 4004781, 4001497, 4101769, 4002398, 4007058, 4004338, 4002575, 4001498, 4004393, 4101638, 4005661, 4005942, 4100432, 4000797, 4000798, 4102801, 1910018, 4000324, 4001410, 4003025, 4003881, 4004868, 4001920, 4003946, 4004225, 4100151, 4100145, 4002183, 4002214, 4003282, 4003503, 4004590, 4006330, 4005981, 4007035, 4007052, 4007059, 4101364, 4004830, 4006355, 4100910, 4101248, 4003565, 4006876, 4006621, 4007099, 4100936, 4001409, 4101834, 4003316, 4004002, 4002220, 4003317, 4004565, 4101409, 4002507, 4003512, 4004793, 4002217, 4003081, 4100973, 4001924, 4002209, 4005235, 4005840, 4100216, 4101408, 4004390, 4004403, 4002846, 4005924, 4004729, 4100906, 4100911, 4100930, 4000185, 4000323, 4001135, 1911127, 4000143, 4000141, 4000164, 4001494, 4001687, 4003521, 4101532, 4101729, 4100129, 4103008, 4005338, 4004715, 1910260, 4001809, 4002587, 4101809, 4001971, 4007106, 4004425, 4005957, 4100147, 4100963, 4003452, 4006934, 4102640, 4002585, 4100722, 4005720, 4005727, 4005038, 4003527, 4101005, 4003451, 4005897, 4101023, 4102951, 4005984, 4003226, 4000465, 4002808, 4003318, 4004831, 4004838, 4005345, 4102534, 4000325, 4004083, 4005678, 4002401, 4005651, 4007103, 4100503, 4102497, 4005170, 4006598, 4000877, 4000883, 4006415, 4003079, 4002915, 4002953, 4006000, 4001263, 4001700, 4003138, 4100971, 4003002, 4004432, 4006599, 4101970, 1906178, 4005239, 4001649, 4004633, 4003458, 4003501, 4002514, 4004643, 4004926, 4007062, 4004773, 4005033, 4101169, 4004761, 4005672, 4004988, 4005261, 4004708, 4002815, 4005952, 4004642, 4004826, 4005974, 4006410, 4006858, 4006949, 4100196, 4100904, 4003478, 4004987, 4001412, 4005890, 4007079, 4005386, 4005767, 4000775, 4001802, 4006975, 4005902, 4003553, 4004454, 4005030, 4004592, 4006335, 4002170, 4101226, 4005668, 4100202, 4103007, 4002583, 4002958, 4003547, 4004700, 4005850, 4004886, 4001416, 4100056, 4100061, 4006004, 4004931, 4005665, 4100743, 4102826, 4001387, 4100705, 4002913, 4102052, 4004637, 4100714, 4003114, 4003880, 4001078, 4005503, 4001506, 1910254, 4004400, 4004861, 4006596, 4101417, 4101915, 4006407, 4002491, 4004404, 4004820, 4002540, 1910141, 4004424, 4101630, 4101685, 4101686, 4005831, 4007076, 4006121, 4102276, 4004697, 4002248, 4005791, 4005846, 4102535, 4002275, 4004441, 4101989, 4100440, 4005028, 4102468, 4006011, 4006811, 4004572, 4003766, 4004286, 4100862, 4005907, 1908876, 4004701, 4100939, 4102835, 4101266, 4100212, 4006305, 4005459, 4102519, 4002763, 4101754, 4002949, 4001407, 4001420, 4001508, 4003511, 4003938, 4002806, 4006937, 4100075, 4100076, 4100080, 4000783, 4000416, 4002442, 4003781, 4003277, 4003389, 4005884, 4005889, 4100054, 4005163, 1900917, 1900975, 1901001, 1906172, 1906174, 1906176, 1907401, 1907466, 1907497, 1908878, 1908968, 1910014, 1910139, 1910143, 1910145, 1910173, 1910221, 1910264, 1911129, 1911838, 4000068, 4000417, 4000419, 4000469, 4000773, 4000776, 4000780, 4000840, 4000878, 4000888, 4000967, 4000970, 4001067, 4001071, 4001139, 4001192, 4001383, 4001419, 4001449, 4001451, 4001495, 4001509, 4001512, 4001514, 4001515, 4001533, 4001540, 4001542, 4001550, 4001636, 4001638, 4001642, 4001646, 4001684, 4001685, 4001689, 4001691, 4001695, 4001703, 4001705, 4001839, 4001841, 4001916, 4002024, 4002025, 4002168, 4002169, 4002189, 4002244, 4002246, 4002306, 4002307, 4002399, 4002419, 4002420, 4002421, 4002423, 4002426, 4002444, 4002446, 4002468, 4002484, 4002485, 4002617, 4002618, 4002622, 4002623, 4002627, 4002725, 4002765, 4003045, 4003053, 4003186, 4003349, 4003767, 4003935, 4003943, 4004033, 4004415, 4004438, 4004458, 4004460, 4004471, 4004472, 4004694, 4004709, 4004727, 4004758, 4004867, 4004990, 4004998, 4005034, 4005245, 4005776, 4005801, 4005838, 4005882, 4006614, 4006978, 4100150, 4100199, 4100490, 4100724, 4100892, 4100912, 4100937, 4100942, 4101001, 4101087, 4101105, 4000167, 4005975, 4000186, 4003537, 4005886, 4001537, 4004730, 4002769, 4005914, 4005443, 4004864, 4101131, 4000993, 4005437, 4000996, 4001997, 4003084, 4003554, 4000774, 4000190, 4004940, 4001496, 1909812, 4003020, 4002375, 4002513, 1910012, 4000969, 4002449, 4002985, 4000847, 4002215, 4007073, 4102059, 4001944, 4001706, 4005342, 1907464, 4001643, 4001681, 4005768, 4007051, 4101137, 4002877, 4004768, 4100064, 4100895, 4001966, 4001191, 4004337, 4004340, 4004943, 4000793, 1910020, 4003522, 4004778, 4101531, 4006823, 4001510, 4100422, 4100433, 4100434, 1906625, 1910016, 4000183, 4002586, 4000153, 4005750, 4003497, 4003538, 4005871, 1907399, 4004576, 4004421, 4004429, 4004837, 4005777, 4004427, 4002539, 4004411, 4101533, 4003729, 4004616, 4000876, 4000884, 4000887, 4006983, 4002578, 4003727, 4004473, 4004832, 4005870, 4004228, 4006592, 4004854, 4006918, 4006935, 4101148, 4003723, 4003596, 4005186, 4005222, 4004439, 4005653, 4005343, 4100041, 4100055, 4100059, 4007066, 1900918, 4002998, 4003117, 4003158, 4005445, 4101684, 4002997, 4003817, 4006929, 4004435, 4003044, 4004634, 4005985, 4003877, 4100207, 4003019, 4002167, 4005867, 4002187, 4005044, 4102922, 4101731, 4102016, 4003496, 4003510, 4005237, 4005786, 4000891, 4004196, 4005040, 4004447, 4102996, 4102208, 4100215, 4005669, 4006854, 4100421, 1911806, 4004457, 4003486, 4005733, 4003878, 4005893, 4003146, 4101466, 4007080, 4005189, 4003426, 4100451, 4100913, 4001076, 4003309, 4005452, 4005456, 4002274, 4006871, 4003468, 4004657, 4004942, 4102553, 4005648, 4001417, 4004928, 4000843, 4001998, 4006124, 4101639, 4005997, 4002210, 4100131, 4004937, 4001635, 4003189, 4100444, 4001075, 4001513, 4003592, 4006798, 4005045, 4000890, 4004434, 4003514, 4005746, 4100135, 4005742, 4000880, 4102055, 1910147, 4003057, 4004780, 4002354, 4004332, 4101101, 4102273, 4102627, 4102950, 4005387, 4100420, 4006492, 4006016, 4005811, 4003815, 4102420, 4003479, 4003314, 4005382, 4005491, 4005640, 4102277, 1910314, 4000995, 4002212, 4101711, 4001493, 4003550, 4004112, 4005671, 4003477, 4003494, 4003500, 4003505, 4003507, 4003513, 4003628, 4003508, 4005043, 4000965, 4000971, 4003042, 4004036, 4004626, 4005677, 4005847, 4005851, 4005853, 4005876, 4005895, 4005903, 4005921, 4005980, 4004445, 4004446, 4004874, 4001202, 4000322, 4000471, 4005973, 4101176, 4001388, 4101136, 4001072, 4001134, 4000873, 4000886, 4001803, 4002185, 4003193, 4005259, 4100861, 4003425, 4003232, 4005161, 4005162, 4002402, 4002469, 1908972, 4006309, 4004342, 4004005, 4000184, 4004849, 4101627, 1910256, 4002213, 4002728, 4003732, 4005134, 4005918, 4102994, 4004651, 4004653, 4004189, 4003046, 4004813, 4004927, 4005932, 4000998, 4006483, 4101529, 4102722, 4000781, 4002488, 4003049, 4006411, 4101631, 4102915, 4005670, 4002400, 4101002, 4006795, 4006001, 4002630, 4100832, 4006436, 4102800, 4003816, 4004851, 4003568, 4004190, 4004227, 4004236, 4004239, 1911125, 4001704, 4000336, 4005859, 4000328, 4002954, 4003219, 4101700, 4005233, 4003546, 4003780, 4005856, 4101909, 4005195, 4101106, 4005505, 4001507, 4102948, 4101912, 4001069, 4002245, 4101391, 4003148, 4005250, 4006594, 4005130, 4004865, 4001425, 4003558, 4002994, 4002301, 4004624, 4003474, 1911808, 4102762, 4003524, 4000422, 4001505, 4100450, 4102122, 4004341, 4101692, 4001838, 4005888, 4005908, 4006412, 1911945, 4102829, 4102758, 4002241, 4101705, 4101135, 4002986, 4003041, 4000470, 4000997, 4002758, 4002766, 4101202, 4101000, 4002222, 4100091, 4100711, 4006364, 4102018, 4001068, 4004597, 4101273, 4005784, 4001538, 4001413, 4101762, 4101474, 4003543, 4101205, 4000334, 4004193, 4101760, 4001065, 4004704, 4001535, 4003629, 4101640, 4000188, 4000413, 1893197, 4000842, 4004420, 4001640, 4102058, 4004282, 4101020, 4102013, 1910258, 4000333, 4002490, 4001074, 4005774, 4002184, 4002302, 4002304, 4002305, 4004084, 4004086, 4102314, 4100972, 4002920, 4102546, 4006872, 4005986, 4004629, 4101246, 4000972, 4003534, 4100482, 4002353, 4003383, 4003587, 4101177, 4101643, 40058... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0435-2026%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, Ukraine, United Arab Emirates, and United Kingdom. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Nov 12, 2025 - **Recall initiation date**: Oct 9, 2025 - **Center classification date**: Nov 6, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0435-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [B-K Medical A/S records](https://isitonrecall.com/brand/b-k-medical-a-s/)