Class II Recall

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

Summary

The FDA issued a Class II for Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System by B-K Medical A/S. 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 rep.

Details

Source

Device Recall

External ID

Z-0436-2026

Action Date

2025-11-12

Status

Ongoing

Product Description

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

Lot/Code Info: 1) 1300-21: GTIN 05704916001285 and pending, Serial Numbers: 2002690, 2008466, 2008495, 2006774, 5012683, 5013881, 5012684, 2008725, 2008280, 2004419, 5012980, 2007101, 2009029, 5014333, 2003852, 2002851, 2002142, 2005860, 5013937, 2007188, 2002950, 2003495, 2008470, 5013934, 5013935, 5016211, 2005193, 5014141, 5014514, 5015892, 5012104, 2009012, 2009153, 5012976, 2008185, 2008137, 5012307, 5014139, 2000774, 2006237, 2008144, 5012319, 5014906, 5012789, 5015458, 2006602, 2004379, 2007123, 2008242, 5011353, 2007736, 5014803, 2006235, 5011354, 2002049, 2005281, 5015083, 5015087, 2008527, 5016292, 5016477, 5012055, 5012326, 5015201, 2003658, 2008735, 5011807, 2005450, 2007082, 2009247, 2009142, 2003588, 5016079, 5016301, 2009108, 2008244, 2003721, 2008663, 2008277, 2006691, 5016299, 2008383, 2006881, 5016300, 2006131, 2001918, 2002172, 2005832, 5015218, 2008792, 5011799, 2003137, 5016193, 5016194, 5012310, 5016082, 2008597, 5011479, 2006483, 2001865, 5012954, 5011802, 2002891, 2008356, 2006359, 2004290, 2002824, 2002177, 5011817, 2003597, 2004373, 5013278, 5013126, 5011800, 5011482, 2004264, 2004295, 5015904, 5014266, 2004372, 2005640, 2001433, 2005658, 2006084, 5012545, 2008386, 2002443, 2008578, 2003686, 2002325, 2001425, 2003150, 2003470, 2008080, 2006885, 2004466, 2008586, 2008472, 2000782, 2000821, 2000862, 2000902, 2000906, 2000914, 2000917, 2003502, 2003594, 2003682, 2003854, 2004519, 2008461, 5010293, 5010925, 5010926, 5010927, 5010929, 5010930, 5010933, 5010934, 5010935, 5010936, 5010938, 5010939, 5010940, 5011142, 5011145, 5011152, 5011154, 5011156, 5011157, 5011160, 5011346, 5011348, 5011351, 5011352, 5011355, 5011461, 5011471, 5012558, 5012566, 5012568, 5012618, 5012682, 5012688, 5012788, 5012964, 5012968, 5012979, 5013125, 5013407, 5013479, 5013656, 5013806, 5013888, 5013889, 5013933, 5014272, 5014432, 5014530, 5015215, 5015217, 5015717, 5016212, 5016294, 2004972, 2006142, 2002845, 2004149, 2007679, 5014334, 2006557, 2006563, 2002052, 2001021, 5013880, 2002289, 5016200, 2008100, 2008685, 2008111, 5012410, 5012547, 2003851, 5012103, 2003684, 5014267, 5012691, 5012790, 2006995, 2008150, 2009155, 2007803, 5013936, 5015456, 5012784, 2008690, 2003710, 2008055, 5013134, 5016204, 2003012, 2002596, 5014819, 2006797, 5013822, 5014904, 2002170, 5015919, 5011465, 5016305, 2002522, 2001145, 2005261, 2008059, 2006635, 5012792, 2002915, 5016096, 2006500, 2006239, 2008501, 2004431, 2003685, 2008902, 2003878, 2005336, 2007801, 2007804, 2006957, 2008287, 2001857, 5011818, 5016085, 2004210, 2001650, 2003676, 2005826, 2005834, 5016467, 2001655, 2008499, 5014283, 2002844, 2001888, 5014204, 5014271, 5012327, 2006271, 5011347, 2000514, 2001148, 2005906, 5015893, 5016007, 2005851, 2008257, 2007728, 2002710, 2001826, 2008249, 2008800, 2003860, 2002016, 2002907, 2002917, 2003056, 2007562, 2003447, 2004296, 2005612, 2002882, 2003144, 2007824, 2008098, 2002708, 2002531, 5014901, 5015998, 5016319, 5016081, 2004395, 5014823, 2001417, 2007781, 2005306, 5011148, 5012052, 2003183, 2006502, 2002904, 5016461, 2002664, 2006274, 2006678, 5011821, 2003499, 2003560, 2003583, 2003617, 2008485, 2003821, 2001458, 2001481, 2001485, 2001487, 2008741, 2006113, 2002589, 5016317, 2008140, 2001645, 2006309, 2006369, 2006458, 2006475, 2006561, 2006566, 2006595, 2006620, 2006778, 2006934, 2006997, 2007167, 2007526, 2007558, 2006987, 2007036, 2008039, 2008161, 2008235, 2009248, 2005330, 2008713, 2003486, 2004191, 2002184, 5015355, 2005731, 5013279, 2005500, 2005825, 2006261, 2005414, 2003492, 2008050, 5014818, 5016302, 2007268, 5015712, 5015711, 5015917, 2008694, 2000822, 2008536, 5011820, 5012317, 2002789, 2008679, 5015411, 5015441, 5015918, 2001695, 2006249, 2001171, 2001936, 2002714, 2007281, 2004128, 5016458, 5012783, 2009187, 5012312, 2001861, 2007305, 2009077, 2008502, 2008743, 2003677, 2003667, 2003747, 5012957, 2005322, 2004982, 2005009, 2007270, 2002420, 2008045, 5012970, 5016090, 2002825, 2006147, 5014510, 5015910, 2008379, 2007808, 5013655, 2008143, 2008201, 5012565, 2002135, 2002150, 2002151, 2002152, 2001426, 2008375, 5013887, 2003630, 2008145, 5011467, 2008279, 2003797, 2006525, 2002575, 2004249, 2003624, 2007032, 2006318, 5013459, 5013886, 2003626, 2003399, 2005277, 2005248, 2008389, 2007627, 5015205, 5015208, 2008708, 2008977, 2008160, 5012960, 5014277, 2008726, 2001843, 2006313, 2007313, 5013463, 2008681, 5016201, 5014919, 5014335, 5016080, 2003355, 2003510, 5013890, 5013132, 5012955, 2001758, 2008246, 2008265, 2007061, 5012051, 2007614, 5012785, 2005638, 2008717, 2008518, 2006672, 2001031, 5014921, 2002458, 5015024, 5011485, 2008899, 2006496, 2006521, 2008061, 5013871, 2006107, 2002813, 2004293, 5015216, 2008387, 2008154, 5012546, 5012548, 5014332, 2008200, 2006230, 2003006, 5016086, 2002143, 2006247, 2002341, 2002889, 2009107, 5012539, 2005517, 2007004, 5015715, 2004375, 2002862, 5011458, 2008253, 2008459, 2008487, 2008493, 2008512, 2008516, 2008524, 5015913, 2005531, 2005537, 2005332, 2003754, 2004647, 2005417, 2004374, 2003612, 2003794, 2007178, 2004203, 2006495, 2007018, 2006998, 2006787, 2007173, 5015716, 2004243, 2002846, 2006862, 2002394, 2002414, 2002885, 2003410, 2003449, 2006215, 2003446, 2003467, 2006860, 5015025, 5013283, 2002332, 2003445, 2003057, 2005528, 2005534, 2001766, 2006132, 2004386, 2003448, 2003179, 2002140, 2004435, 2006661, 2001651, 2006278, 2000712, 5012791, 2003581, 5014801, 5014802, 2001137, 2002051, 2000780, 2002047, 5014136, 5014269, 5014822, 2001701, 2001713, 2001783, 2002338, 5014216, 2008083, 2008125, 2008156, 2008511, 2008734, 2008779, 2009157, 5011483, 2007748, 5011484, 2006988, 2003468, 2000403, 2001084, 2001086, 5014138, 5015446, 2000771, 2006411, 2000281, 2000479, 2000785, 2000248, 5014527, 2000322, 2004287, 2004260, 2002783, 5015444, 5013130, 5012402, 2000164, 5014215, 2005751, 2000577, 2003614, 2007273, 5016077, 5016078, 2002048, 2003586, 2005364, 2001297, 2005755, 2007680, 2004455, 2000467, 5014814, 5014816, 5011161, 2005396, 5014912, 5015699, 2000828, 2001688, 5011812, 5011824, 5015657, 5014140, 5014808, 5014807, 2000504, 2003816, 2001073, 2001478, 2007678, 2007785, 2007792, 2008521, 2008738, 2008765, 5011466, 5013829, 5014331, 5016014, 2006391, 2000109, 2002337, 5011361, 5011363, 2002444, 2005653, 2006242, 5016089, 5014222, 2004412, 5014214, 5014526, 5014536, 2008490, 5014824, 2007524, 5016293, 2004135, 2002782, 2002017, 2005786, 2002709, 2002400, 2001641, 2005001, 2005765, 2007067, 5014221, 2000993, 5010923, 5012315, 5011809, 2002878, 5013135, 2009048, 2009140, 2003496, 2003546, 2005490, 5011462, 5011463, 5012786, 5014820, 2005723, 2006530, 2002881, 2000202, 2002178, 2005462, 2008748, 5010937, 5011149, 5012556, 5012557, 2000245, 2000507, 5014761, 5011151, 2006667, 2002456, 2002459, 2002499, 2002523, 2002524, 2002526, 2002527, 2002528, 2002533, 2002544, 2000908, 2004951, 2001200, 2001264, 2006385, 2000713, 2002280, 2002281, 2002284, 2002811, 2006167, 5012974, 5014223, 2000275, 2001026, 2001685, 2001694, 2002344, 2002801, 2003060, 2003551, 2003659, 2003683, 2003757, 2003763, 2003843, 2004131, 2005449, 2006731, 2008232, 2008546, 2008570, 5011365, 5012563, 5014133, 5015006, 5015914, 5015915, 2005456, 5015358, 5015359, 5012917, 5012314, 5011819, 5015453, 5015455, 5013291, 2001535, 2005952, 5013952, 2000207, 2001796, 5013296, 5014421, 2006877, 5013474, 2000556, 2000558, 2005551, 2000569, 2000907, 2003853, 2005738, 5014815, 2001935, 2003009, 5011806, 2003650, 2005965, 5014798, 5015079, 2000172, 2004984, 2002787, 2006352, 2000168, 2002839, 2000179, 2002210, 2007125, 2001785, 2003838, 2000196, 2006611, 2005259, 2003469, 2006749, 2009137, 2009123, 2003471, 2003475, 5014446, 5015459, 2001938, 5013120, 2002549, 2002598, 2007117, 2005603, 2001090, 5013114, 5015647, 2005455, 5013953, 5015649, 5015650, 2003013, 2006705, 2006537, 2003443, 2007010, 2000578, 5014923, 2001893, 5011147, 2006280, 2006449, 2002841, 2002842, 5014817, 2003348, 2003708, 5013111, 5015448, 2006588, 5011804, 2006714, 2002335, 2005694, 5011810, 2000545, 2001088, 2001172, 2005683, 2005684, 2000321, 5013124, 2000474, 2007286, 2005326, 5011805, 2002806, 2007726, 5015351, 2003479, 2000108, 2000784, 2007729, 2003837, 2001677, 2001764, 5014909, 5014911, 5014130, 2000732, 5012983, 2003709, 2006932, 2006386, 2005812, 5011803, 5014203, 5013404, 2002502, 5014805, 2000861, 5011459, 5011478, 2000638, 5016017, 5016018, 2000816, 2005474, 2005478, 2006606, 2006609, 2007012, 2007523, 2007554, 5015447, 2007513, 5015865, 5016076, 5011153, 2000775, 2001079, 5013112, 5010931, 5014821, 2005240, 5015648, 2002780, 2000478, 2003755, 2007011, 2007052, 2007063, 2007083, 2007601, 5014917, 5016008, 5016009, 2006694, 2006832, 2003547, 5011487, 2002884, 2002399, 2001385, 2003180, 2006599, 2006621, 5012562, 5012685, 2002578, 2002546, 2004639, 2000230, 2006328, 2000395, 2004610, 2006654, 5015646, 2002776, 2005318, 2004282, 5012302, 2002020, 2003351, 2004163, 5013299, 5013473, 5014135, 5014420, 2000269, 2003756, 2003820, 2004280, 2004298, 2004376, 2004385, 2004403, 2004537, 2004545, 2004547, 2004592, 2004601, 2004617, 2004777, 2004794, 2004948, 2005010, 2007527, 2000773, 2006789, 2002214, 2005588, 5013467, 2000703, 2003481, 5013475, 2001461, 2000263, 2001895, 2005360, 2005368, 2006338, 5014903, 5013469, 2002659, 2000415, 5014137, 2000411, 5013636, 2001432, 5013637, 2003472, 2005476, 2006337, 2000352, 2004439, 2002583, 2002847, 2006719, 2005705, 5011159, 5013274, 2001649, 2001930, 5014908, 2000739, 2007119, 2000278, 2007553, 2007737, 2000829, 2003742, 2006849, 2003672, 2001467, 2001793, 2007093, 5011475, 5014343, 5011460, 2002614, 5014210, 2007669, 2007790, 2008057, 2008082, 2008148, 2008205, 2008240, 2008332, 2008336, 2008337, 2008347, 2008352, 2008358, 2008376, 2008477, 2008548, 2008665, 2008712, 2008758, 2008761, 2009035, 2009062, 2009066, 2009082, 2009120, 5010924, 2000469, 2000356, 2003408, 2006613, 5012795, 5012916, 2006233, 2002288, 2000396, 5016189, 2005610, 2007130, 2007331, 2007332, 2007551, 5011801, 2000353, 5015070, 2000813, 5015639, 2000778, 5011144, 2006098, 2002144, 2001816, 2002019, 2003504, 5015638, 2006251, 2001135, 2000553, 2002859, 2001501, 2004638, 2003836, 2001896, 2007103, 2006717, 2007089, 2004202, 2005778, 2002520, 2003849, 2002138, 2001163, 2001648, 5013821, 2000818, 2002850, 2004954, 2001001, 2004953, 2006818, 2006880, 2007145, 2008060, 5011464, 2002922, 2005267, 2005572, 2007516, 2008673, 2002886, 2002948, 2002952, 2006582, 2007006, 2007565, 5015010, 5015011, 5016306, 2002342, 2002909, 2005457, 2005805, 2006878, 2008131, 2008191, 2005743, 2008773, 5011364, 2002495, 2003509, 2002573, 5011474, 2000547, 5011477, 2005571, 2003065, 2008262, 2005472, 2000576, 2001465, 2002874, 2000995, 5011480, 5011481, 5011808, 5012971, 2008492, 2006067, 5015198, 2007007, 5013128, 2000517, 2002828, 2005836, 5014764, 5014806, 2002840, 2007031, 5013131, 5015193, 5015194, 5015195, 5015196, 2004281, 2009185, 2009172, 2009196, 2003629, 5015634, 5013954, 2000825, 2000276, 5014910, 5015353, 5015875, 5011350, 5014433, 5014442, 5014673, 5014678, 2006119, 2003545, 2003669, 5014330, 5014760, 5014762, 5014763, 2005523, 2003675, 2004014, 2003824, 5012921, 2005590, 2005841, 5013119, 2001004, 2000830, 2001369, 2001372, 2001375, 2001376, 2001378, 2003396, 2004443, 2005507, 2006639, 2000268, 2000270, 2000272, 2002333, 2003409, 2003613, 2003705, 2005320, 2005334, 2006117, 2006306, 2006660, 2006770, 2007295, 2007806, 2008728, 5011811, 5013282, 5013882, 5014795, 2006882, 2007005, 2008784, 5015698, 2002416, 2007013, 2008058, 5011146, 2000198, 2001205, 2001260, 2003736, 2004158, 2005335, 2005569, 2005581, 2005595, 2005599, 2005602, 2005605, 2005988, 2006535, 2006568, 2007127, 2007338, 2007520, 2007603, 2007670, 2007681, 2007690, 2007691, 5014211, 2008245, 2000472, 2000483, 2001518, 2005333, 2005941, 2006248, 2007528, 2007557, 2008341, 2008355, 2008483, 5012050, 2007166, 5015903, 2002314, 2003117, 2003557, 2000200, 5011143, 5012108, 2002391, 5011357, 2002918, 2008118, 2008289, 2008790, 5011150, 2009000, 2008825, 5013805, 2002211, 2000854, 2002182, 2004550, 5011472, 5013292, 5013295, 5013300, 5013406, 5013413, 5013464, 5014426, 2001019, 5013281, 5013287, 5015713, 5015714, 2000110, 2000232, 5011359, 5014448, 2000919, 2001656, 2001708, 2002294, 2001810, 5014796, 2002802, 5014905, 2000920, 2006647, 2006655, 2007185, 5012693, 2004978, 2001824, 2001923, 2000389, 2003788, 5012973, 5011356, 5013277, 2002698, 5014134, 2001206, 2001204, 5015021, 5016213, 5016214, 5011827, 5013899, 5015197, 2003850, 2007170, 5011358, 5011360, 5011362, 2003478, 2003759, 2001209, 2006149, 5012961, 2001164, 2004508, 2004521, 5012159, 5012303, 5012553, 5014419, 5016010, 2002791, 2002704, 5013129, 5015853, 2003740, 2007102, 2007143, 2007560, 2007567, 2007671, 2007706, 2007718, 2008737, 2008752, 2008762, 2000737, 2001201, 2001213, 2003487, 2004453, 2005894, 2006254, 5015891, 5013654, 5014804, 5014913, 2001027, 5012411, 5014427, 2001852, 2005771, 2006073, 2008076, 5015331, 2004292, 2003205, 2003519, 2000387, 2002043, 2004446, 5011349, 5014922, 2003236, 2006839, 2003653, 5012787, 5013950, 2003610, 5011158, 2005981, 2003587, 2003402, 5012978, 2003826, 2005676, 2006166, 2005811, 2006172, 2006825, 2009159, 2006814, 2004418, 2004255, 2003628, 2003632, 2005504, 2005511, 2006192, 2000918, 2006811, 2003181, 5013951, 2006424, 2006615, 2008064, 2008065, 2008075, 2008081, 2008110, 2008196, 2008203, 2008711, 2008736, 2008781, 2008901, 2008908; 2) 1300-S1: UDI/DI pending, Serial Numbers: 2007274, 2001754, 2003771, 2003611, 2005842, 2007514, 2004986, 2003773, 2006652, 2006072, 2005329, 2006408, 2005728, 2003239, 2002206, 2006085, 2005444, 2002946, 2005987, 2006453, 5014797, 2006768, 2006876, 2007053, 5016019, 2003453, 2004206, 2004197, 2001387, 2006265, 2003746, 5015897, 2002715, 5016202, 2003656, 2002551, 2007115, 5015916, 2007564, 2001024, 2004362, 2004577, 2002911, 2001922, 2005628, 2005856, 2002860, 2003750, 2006212, 2002945, 2005670, 2002340, 2007676, 2004148, 2003116, 2001822, 5015641, 5016006, 2007141, 2005339, 2003398, 2006066, 2006580, 2003330, 2006228, 2003198, 2001025, 2003579, 2001690, 5015332, 2004299, 2004144, 2007049, 2005190, 2001788, 2002809, 2000921, 2000997, 2001010, 5015643, 5016471, 5016475, 2005532, 2004157, 2006367, 2005840, 2003829, 2007556, 2003412, 2006875, 2004168, 2001300, 2004985, 2005608, 2005837, 2006933, 2002045, 2006589, 2003718, 2007179, 2007687, 2005803, 2005421, 2002803, 2005729, 2002893, 2004271, 2003815, 5016020, 2006666, 2007317, 2004156, 5015340, 2002287, 5015345, 2003118, 2002018, 2002452, 5015719, 5016455, 2002455, 2003689, 2005584, 2002812, 2001937, 2001931, 2003549, 2004142, 2006451, 5015718, 2003680, 2007682, 2001867, 2007068, 2006473, 2003688, 2001170, 2001304, 2005469, 2002613, 2005394, 2006523, 2002879, 5014902, 5016190, 2006204, 2003244, 2001679, 2002148, 5016000, 2004252, 2004460, 5016084, 2001866, 2003762, 2003822, 5015460, 2001752, 5015854, 5015999, 2001827, 2001855, 2005747, 2003678, 2001149, 2001151, 5015334, 5015335, 5015336, 5015706, 5015707, 5016304, 5016210, 2007090, 5013127, 2001784, 2001707, 2001851, 2003748, 2006255, 2005630, 2006201, 2006226, 2005219, 2005485, 2003485, 2006202, 2002147, 2001524, 2002149, 2005617, 2005667, 2005718, 2003484, 2006809, 2002453, 2004253, 5016191, 5016203, 2004279, 2001308, 5015997, 2006643, 2004383, 2004457, 2004536, 2004608, 2004634, 2004635, 2004637, 2004785, 2004796, 2004797, 2004931, 2004946, 2004952, 5015874.

Quantity Affected: 1697 units

Reason for Recall

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.

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-10-09

Company

B-K Medical A/S

Herlev, N/A

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.

B-K Medical A/S has 8 FDA actions in our database, including 8 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B-K Medical A/S) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does B-K Medical A/S have FDA actions?

B-K Medical A/S has 8 FDA actions in our database, including 8 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0436-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

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