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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97830

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 09, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
B-K Medical A/S

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

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

Z-0435-2026
Recall number
Z-0435-2026
Initiated
October 09, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B-K Medical A/S
Quantity
4426 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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Distribution pattern

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.

device · product 2 of 6

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

Z-0436-2026
Recall number
Z-0436-2026
Initiated
October 09, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B-K Medical A/S
Quantity
1697 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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.

Distribution pattern

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.

device · product 3 of 6

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

Z-0437-2026
Recall number
Z-0437-2026
Initiated
October 09, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B-K Medical A/S
Quantity
567 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

GTIN 05704916000264 and pending, Serial Numbers: 2008018, 2003427, 2008941, 2005905, 5014230, 2008447, 2005014, 2005669, 2006518, 5013628, 2007486, 2004009, 2004033, 2005897, 2004848, 2005428, 2005443, 2001579, 2002735, 5015492, 2008928, 2008949, 2002410, 2005561, 2004928, 2005883, 2005791, 2004802, 5016163, 2006012, 2003156, 2001915, 2004930, 2008654, 2004644, 2004812, 2007365, 2001350, 2008922, 2005945, 2003228, 2006454, 2005870, 2006185, 2007470, 2002654, 2003100, 2007539, 5014068, 5013784, 2003912, 5015223, 2001558, 2002650, 5011926, 5012262, 2001517, 2001354, 2008589, 2008411, 2006490, 2004572, 5010710, 2002822, 5015605, 5014242, 2003084, 5016412, 5012648, 2003324, 5009250, 5009251, 2002232, 2002346, 2005369, 5014235, 5016277, 2008650, 2008905, 2006432, 2004787, 2005721, 2006037, 2008891, 2006751, 2001448, 2003531, 2002506, 2007347, 2007488, 2004513, 5009252, 2006023, 5013588, 2005314, 2007509, 2002960, 2003433, 2005938, 2005931, 2004809, 2007533, 2002512, 2004174, 2001879, 2008807, 5014405, 2008964, 2007342, 5009257, 5010973, 5012165, 2008198, 2008915, 2008882, 2008879, 2008920, 2008855, 5011928, 2006822, 2008438, 2007599, 2007542, 2007541, 5013421, 2001451, 2006499, 5016440, 2008894, 2003924, 2003943, 2007536, 2001807, 2004573, 2003257, 2003105, 2004535, 2007576, 2002957, 2004274, 2007490, 2007511, 2001887, 5009680, 2003235, 5011032, 5012533, 2006684, 2007587, 2003230, 2001798, 5016220, 2006033, 2005263, 2005273, 2006671, 5011183, 2008617, 2008333, 5014244, 2006169, 2008439, 2005946, 2003078, 2006843, 5015688, 2006053, 5016042, 2006812, 5015047, 5015109, 2008296, 5013159, 2004184, 2005264, 2008190, 2004061, 5016286, 2004917, 2003533, 2009148, 2002511, 2003082, 2003986, 2008623, 2004062, 5010777, 2000120, 2001453, 2001456, 5013041, 5013042, 2004083, 2004528, 2002104, 5012515, 2001132, 2003077, 2006474, 2008661, 2006168, 2006180, 2006293, 2006303, 2006336, 2006354, 2000956, 2000957, 2003933, 2003936, 2003984, 2006138, 2006206, 2000963, 2007859, 2002406, 2002407, 2005366, 2004912, 2004943, 2005378, 2008391, 2008918, 2006360, 2004272, 2004294, 2004297, 2006459, 2007716, 2007860, 2002651, 2006292, 2005181, 2000952, 2004176, 5012022, 5015377, 2004926, 5016417, 5016425, 5016426, 2005371, 2007506, 2005499, 5016444, 2000798, 2004396, 5015489, 5011703, 5014069, 2002507, 2000960, 2002821, 2002963, 2007577, 5012076, 2007464, 2008414, 2002225, 2008335, 2008401, 5016027, 5011179, 2008692, 5012040, 5008892, 2008394, 2008420, 2008418, 2002959, 2001349, 5015362, 2004267, 2003527, 2007640, 2005881, 2000959, 2004598, 2008658, 2001450, 5011174, 2000879, 2004810, 2006068, 2007459, 2008817, 2005362, 2007489, 2001509, 5013150, 5013164, 5013231, 5015723, 2006728, 2006901, 2004182, 5015603, 5014120, 5016340, 2006425, 2001115, 2001118, 2001128, 5016245, 5016246, 2005431, 2006470, 5014065, 5009661, 2008408, 2004929, 2005963, 5008907, 2007457, 2004822, 5009495, 5009596, 2006003, 2002409, 2005930, 5013023, 5012164, 2006755, 2004672, 5012536, 2006734, 5007896, 5007893, 2001561, 2005739, 2005741, 2005746, 2003561, 2007456, 2002616, 2006396, 2002112, 2002242, 2002404, 2002508, 2002235, 2004691, 5012926, 2008019, 5016273, 5016274, 2008636, 2008014, 2004925, 5015229, 5016338, 2003934, 5011420, 2004063, 2005901, 5014119, 5010411, 5014313, 5012161, 2002739, 5012338, 2006415, 2005359, 2001514, 2007585, 2002230, 2006384, 2006438, 2003129, 2004803, 2004805, 5009592, 2007535, 2004641, 2007499, 5016441, 5012535, 5013783, 5016275, 2001455, 5014830, 5016439, 2007324, 2004032, 5014404, 5008183, 2004615, 2000954, 5015606, 2000666, 2000667, 2002742, 5013317, 2004514, 5012078, 5013613, 2002620, 2003096, 5009508, 5011329, 5011947, 5011224, 5011318, 5011162, 5011946, 5011187, 5016241, 2004657, 5013032, 5008140, 5008673, 5013850, 2001120, 2003234, 5016168, 5016169, 2004048, 5011726, 2005508, 5015406, 2001911, 5011317, 2001914, 2005542, 2003076, 5012446, 5012589, 2004016, 2004007, 5013422, 2000613, 2000796, 2004549, 2004825, 5011031, 2000612, 2000615, 2001345, 5016136, 2004001, 2002106, 2002110, 2006815, 2006435, 2006534, 5013229, 2000962, 2003265, 2008951, 2006680, 2008017, 2008269, 2008326, 2008397, 2008409, 5013379, 2009219, 2008952, 2001508, 5008056, 5016328, 2004169, 2005867, 5013249, 2001126, 5008054, 2007479, 2002402, 2002403, 5013629, 2001131, 2001288, 2001800, 2003080, 2003085, 2003099, 2003102, 2003128, 2003264, 2003272, 2005576, 5015102, 5015412, 5011702, 5015985, 2009228, 5011838, 5009718, 5008889, 2006030, 5014503, 2003888, 2002228, 5011320, 5012162, 5012166, 5014777, 2003978, 2004382, 2001291, 2000117, 2006556, 2003127, 5012928, 2004660, 2004804, 2006393, 2008416, 2008427, 2008614, 2004276, 2004392, 2006405, 2008429, 5014504, 5015981, 5013845, 5008676, 5007898, 5010752, 2007473, 5008908, 5015484, 5008677, 2005817, 2004015, 2005757, 2005911, 2005342, 2003945, 2003975, 2007467, 2003306, 2003922, 2006029, 2005830, 2003961, 2003131, 5013031, 2003885, 2003887, 2003886, 2001353, 2004008, 2004913, 2005993, 2003261, 2006891, 2005854, 2005750, 2004548, 2005353, 2002623, 2002656, 2002738, 2006805, 2003921, 2004041, 2005763, 2007812, 2008023, 2008025, 2008612, 2008863, 2008867, 2004927, 2006115.

Distribution pattern

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.

device · product 4 of 6

bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

Z-0438-2026
Recall number
Z-0438-2026
Initiated
October 09, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B-K Medical A/S
Quantity
496 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

GTIN 05704916000264 and pending, Serial Numbers: 5016428, 5016429, 5016430, 2009154, 2008179, 2004456, 2007484, 2005976, 2007361, 2009167, 2003895, 2004700, 2008564, 2008948, 2004560, 2008452, 2008423, 2005567, 2006788, 2002815, 2008537, 2008687, 2003294, 2005833, 2008560, 2005374, 2008151, 2008871, 2008873, 2007476, 2002562, 2005398, 2005950, 2008456, 2004746, 2004957, 2006757, 2001059, 5016374, 2006796, 2001364, 2004636, 2008856, 2008935, 2002361, 2005934, 2008793, 2008194, 2003909, 2006125, 2008230, 2008254, 2008489, 2008553, 5016508, 2005822, 2009176, 2001734, 2007607, 2007483, 2001065, 2007453, 2007710, 2004474, 2004670, 2004737, 2008881, 2004632, 2005554, 2007632, 2003894, 2005918, 2006074, 2006682, 2006840, 5016482, 2005845, 2006294, 2006298, 2007485, 2005580, 5016272, 2001735, 2003293, 2006659, 2003287, 2007692, 2007725, 2007693, 2008451, 2008886, 2007724, 2003890, 2001729, 2005522, 2006364, 2007711, 2008471, 2004725, 2004735, 2007491, 2008182, 2002118, 5016451, 2007325, 2007363, 2007454, 2007455, 2005564, 2005798, 2008914, 2005797, 2005821, 5016505, 5016509, 2007650, 2008218, 2001728, 2008159, 2003288, 2001366, 2004364, 2004368, 2009156, 2008146, 2008210, 2008530, 2004363, 2002120, 2000761, 2003776, 2008522, 2008892, 2002001, 2004482, 2005382, 2003170, 2003171, 2005191, 2007477, 2005303, 2002117, 2005973, 2005220, 2007356, 2008562, 2007649, 2005951, 2004686, 2008481, 2005201, 2003896, 2005903, 2005912, 2005947, 2005966, 2006008, 2001999, 2005882, 2004962, 2002565, 2008167, 2008900, 2001359, 2005413, 2006720, 2008684, 2008925, 2006604, 2004387, 2008864, 2008874, 2002114, 2002559, 2003942, 2009173, 2008248, 2008266, 2007653, 2005171, 2008450, 2001057, 2001064, 5016507, 2006006, 2004652, 2007492, 2001363, 2008497, 2001737, 2005298, 2008857, 2001063, 2005919, 2007359, 5016415, 2003167, 2006673, 5016416, 2008866, 5016506, 2008963, 2005543, 2007684, 2006826, 2004695, 2008880, 2008251, 2009256, 2002556, 2002563, 2002115, 2006773, 2007761, 2006857, 2008243, 2008268, 2003174, 2006308, 2006605, 2005968, 2008227, 2005390, 2008854, 2002003, 2002005, 2008453, 2005275, 2008508, 2007481, 2002557, 2005801, 2002007, 2002000, 2005192, 2004459, 2004559, 2004654, 2004712, 2004720, 2008202, 2008868, 2005225, 2000765, 2002002, 2008927, 2006057, 2002116, 2003962, 2005898, 2006493, 2007683, 2005294, 2005317, 2005254, 2004692, 2004696, 2004365, 2004447, 2004789, 2002006, 2006078, 2009263, 2007360, 2007498, 2001361, 2001367, 2003168, 2007631, 2008550, 2008937, 2005265, 2002819, 2001362, 2003295, 2005386, 2003883, 2003957, 2004409, 2004627, 2003906, 2007355, 2004450, 2006080, 2005924, 2002119, 2002121, 2005373, 2003166, 2001360, 2006527, 2004452, 2002816, 2002818, 2001730, 2006127, 2001998, 2008689, 2006063, 2008241, 2007451, 2006096, 2006296, 2006358, 2005278, 2007609, 2007610, 2007497, 2008878, 2008953, 2007478, 2007702, 2005379, 2008606, 2001731, 2004394, 2008579, 2002122, 2004485, 2001732, 2007654, 2005926, 2005354, 2005954, 2005925, 2005187, 5016341, 2006777, 2004527, 2004448, 2004451, 2006092, 2002004, 2007354, 2001066, 2005975, 2007463, 2001736, 2004667, 2004685, 2002820, 2003893, 2001060, 2000763, 2005974, 2002558, 2002817, 2004633, 2005955, 2004529, 2004415, 2005405, 2007452, 2005540, 2005168, 2000762, 2003859, 2004366, 2004390, 2004477, 2004713, 2004748, 2005215, 2005304, 2007328, 2004749, 2001365, 2005308, 2005365, 2004541, 2004719, 2006833, 2007531, 2005593, 2003175, 2003173, 2005579, 2005719, 2000764, 2001058, 2003292, 2004054, 2006134, 2008169, 2008233, 2008271, 2008323, 2008325, 2008535, 2008556, 2008568, 2008870, 2008872, 2008960, 2009188, 2008958, 2004053, 2006095, 2001062, 2005313, 2005395, 2007701, 2007326, 2004752, 2007353, 2004539, 2008237, 2008421, 2008797, 2005942, 2006603, 2007482, 2007629, 2007734, 2002564, 2007322, 2005902, 2008954, 2004738, 2003286, 2004449, 2007357, 2007358, 2006061, 2008859, 2005742, 2008921, 2002264, 2004732, 2002113, 2002814, 2004642, 2007636, 2005295, 2005389, 2007461, 2008141, 2008327, 2008791, 2008801, 2008883, 2008916, 2008682, 2008861, 2008934, 2008955, 2008950, 2004745, 2006282, 2006481, 2006784, 2005305, 2001061, 2001368, 2001733, 2005388, 2006790, 2008515, 2006665, 2008513, 2007635, 2004731, 2006699, 2005383, 2003963, 2005849, 2004012, 2006076, 2005933, 2006059, 2006345, 2006373, 2005401, 2003777, 2003881, 2003862, 2004462, 2004407, 2003959, 2004664, 2006093, 2006128, 2003172, 2003917, 2005410, 2005375, 2005802, 2003897, 2003958, 2007462, 2008155, 2008163, 2008173, 2008258, 2004389, 2004684.

Distribution pattern

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.

device · product 5 of 6

bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic

Z-0439-2026
Recall number
Z-0439-2026
Initiated
October 09, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B-K Medical A/S
Quantity
124 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

GTIN 05704916000264 and pending, Serial Numbers: 5009743, 5009345, 5009346, 5009353, 5007595, 5007746, 5009358, 5009726, 5009021, 5008627, 5008542, 5008280, 5008994, 5007594, 5008019, 5009344, 5009000, 5009001, 5009002, 5009339, 5009340, 5009722, 5013052, 5013067, 5008617, 5007733, 5009361, 5008995, 5009357, 5008012, 5009732, 5006923, 5007592, 5009019, 5009723, 5009729, 5009003, 5009005, 5008271, 5009730, 5007422, 5009747, 5007424, 5008265, 5008534, 5009012, 5009740, 5008541, 5006928, 5009737, 5009347, 5009348, 5009349, 5009363, 5009720, 5008625, 5009733, 5009360, 5009013, 5009014, 5007429, 5007742, 5009719, 5013351, 5009011, 5009017, 5009727, 5013069, 5008262, 5009020, 5007850, 5009335, 5009336, 5007609, 5009004, 5007608, 5007857, 5009338, 5009725, 5009351, 5009724, 5008147, 5009350, 5009352, 5008623, 5009738, 5008996, 5008274, 5013610, 5009341, 5013591, 5009742, 5008551, 5009741, 5008053, 5008269, 5008018, 5008267, 5009010, 5009739, 5013423, 5007426, 5007611, 5007855, 5009745, 5009734, 5007738, 5008533, 5008014, 5008270, 5008536, 5009007, 5008545, 5008281, 5009342, 5009343, 5009728, 5009735, 5009736, 5009746, 5013319, 5013325, 5013586, 5008626.

Distribution pattern

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.

device · product 6 of 6

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

Z-0440-2026
Recall number
Z-0440-2026
Initiated
October 09, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B-K Medical A/S
Quantity
895 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

GTIN 05704916000264 and pending, Serial Numbers: 2002509, 2008698, 2006429, 5013043, 2008314, 2002617, 5016133, 5013054, 2005257, 2003097, 2003133, 2002655, 2001908, 2001567, 2001587, 5014656, 2001346, 2003432, 5015936, 5015937, 2007537, 2007493, 2007508, 2005573, 2003569, 2005652, 2002618, 5015938, 5015966, 2007534, 2005979, 2002510, 2003079, 2003083, 5013847, 2003532, 2003535, 5015614, 5015616, 5015617, 5015677, 5015720, 5015721, 5009669, 2003562, 5015927, 2001804, 5015611, 2008819, 2004819, 2004816, 2004939, 5016388, 5016390, 5009259, 5016395, 5015600, 5014860, 5008890, 5016164, 2000873, 2000878, 2000118, 2000880, 2001884, 5008010, 2003034, 5014063, 2006387, 5015116, 5010745, 5014406, 5014407, 5014408, 2008604, 5010979, 5010322, 5010408, 2003564, 2006191, 5014975, 2006407, 2005904, 2005920, 2006218, 5013389, 5011535, 2005357, 5011225, 2006894, 2005844, 2003526, 2003568, 5009258, 2005666, 2003923, 2009162, 2009149, 2008912, 2004177, 2004782, 2006039, 2005657, 2001916, 2001917, 5014174, 5008020, 2000876, 5015684, 5009371, 5009665, 2007644, 5011701, 5013040, 5014121, 5014655, 5014657, 5015225, 5015228, 5015924, 5015925, 2002652, 5012534, 2006422, 2007460, 2002405, 2001515, 2001516, 2004114, 2004438, 2008630, 2008811, 2003528, 2007507, 5015986, 2004121, 5014351, 2003434, 2006071, 2007573, 2006657, 2007540, 5016233, 5013794, 2001565, 2008024, 2008324, 5014992, 5016448, 2007466, 5015363, 2005816, 2005957, 2005964, 2006769, 2006829, 2001119, 2001122, 2003229, 2006112, 2006139, 2006203, 2005766, 2007346, 5016222, 2007602, 2009217, 2006457, 2008021, 2008178, 2002227, 2002229, 2002236, 2002237, 5015968, 5007860, 5007902, 5007909, 2001913, 5013051, 5013053, 5016235, 5011226, 2002649, 2003979, 2001583, 5010417, 2003081, 5013232, 5016491, 5016492, 2001123, 2003567, 2003570, 5009254, 5013770, 5015487, 5015491, 5009682, 5016185, 2002103, 2004052, 5016040, 2008930, 2001882, 2001909, 2002244, 5016418, 2003232, 2003259, 2005175, 2006402, 2006441, 2007343, 2007345, 2004840, 5016234, 5016236, 5016240, 5016336, 2002234, 5011170, 5015224, 2003098, 5016490, 5009256, 2003321, 2004594, 2003317, 2006159, 2001559, 2001566, 2001586, 2003563, 2005391, 5013027, 2004662, 2001513, 2006898, 2003101, 2007643, 2002243, 2002560, 2006746, 2008016, 2008706, 2003262, 2006409, 2002240, 2002561, 2002619, 2002624, 2006181, 2008012, 5010412, 5014507, 5015965, 2004690, 5012509, 5012513, 5013340, 5013341, 5009379, 5015686, 5015687, 5013587, 5013589, 5010705, 5013796, 2005762, 2008264, 2008291, 2000792, 2000793, 2000794, 2000795, 2000797, 2000961, 2000967, 2000970, 2000725, 2002238, 2001285, 2008890, 5014730, 5016029, 2000958, 2002111, 2004813, 5014506, 2002241, 2003323, 5013390, 2001449, 2006477, 2002504, 5015722, 5016172, 2007474, 2003530, 2008641, 2001802, 5012455, 5008837, 5008886, 2003258, 2003130, 5014247, 5016396, 5016402, 5016403, 5016404, 5013848, 5015496, 5012852, 5012854, 5014350, 5015230, 5015250, 2002734, 2001560, 2001562, 2001563, 5008008, 2004496, 5016182, 2003982, 5008771, 5010418, 2006390, 2002109, 2004208, 2004678, 5016344, 2006301, 5016041, 5015967, 2007341, 5016183, 2008823, 2004808, 2007458, 5008885, 5008887, 2007532, 5016339, 5010982, 5009370, 5010976, 2008583, 2008615, 5012851, 5009496, 5016337, 2004188, 5013316, 5016414, 5016223, 5015497, 5015612, 5013916, 5013917, 2000872, 2004526, 2005448, 2002164, 2005847, 5014829, 2000955, 2000722, 2001582, 2000611, 2001116, 2000721, 2001347, 2003231, 2000874, 5016242, 5016243, 2000614, 2003319, 2000119, 5009679, 5014374, 2000660, 2004523, 5015227, 5014234, 2008610, 2008632, 2008853, 5009681, 5015493, 5009509, 2007323, 2007480, 2007487, 5011167, 2001130, 5014843, 5007892, 5011250, 5008005, 5008017, 5008668, 2006350, 2002505, 2002955, 2003233, 2003430, 2003431, 2003905, 2003985, 2004542, 2004760, 2004775, 2004907, 2005921, 2003263, 2003320, 2003529, 2003318, 2002622, 2004911, 2007715, 2001878, 2001880, 2001883, 2001886, 2004205, 2008924, 2008177, 2008004, 2008022, 2005376, 5014375, 2005550, 2005274, 2001512, 2006017, 2004085, 2000881, 2003256, 2005582, 2005753, 2003884, 5012528, 2003322, 5015045, 5015108, 5012079, 5012163, 2001799, 5011321, 5016126, 5016413, 5016427, 2004815, 2003920, 2003960, 2005538, 2005545, 5015399, 2001127, 2001564, 2006335, 2001348, 5014658, 5013583, 2005423, 2000664, 5016383, 2000799, 2000800, 2006106, 5015226, 2000618, 2000965, 2008961, 2001124, 2001286, 2001806, 2004776, 2004821, 2005643, 5012252, 5011929, 2006187, 5009582, 2000971, 2000728, 2000730, 5008896, 5016167, 5015046, 5012665, 5011333, 2000619, 2006482, 2002621, 2001578, 5011930, 2006463, 2001885, 2003260, 5013615, 5011330, 2004645, 2000729, 2002939, 2005808, 2004661, 2006419, 2001457, 2000616, 5013356, 5010997, 5014064, 2004924, 2000724, 2004569, 2001352, 5015257, 2002653, 2003435, 5011000, 5014176, 2000668, 5008894, 5011927, 5013630, 5015982, 2004502, 5015607, 5015608, 5015403, 5014991, 5014859, 2006531, 5013357, 5012077, 2002107, 2004115, 5009660, 2003428, 5010211, 2004029, 2009209, 5015486, 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5014725, 5014726, 5012927, 2004934, 5008189, 2005454, 2007344, 2006027, 2006748, 2008028, 2008398, 5009253, 2006016.

Distribution pattern

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.