B-K Medical A/S: UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

Company / brand

B-K Medical A/S

Product

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

Reason / hazard

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

Status

Ongoing

Distribution / sold at

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.

Recall initiated

2025-10-09

Code info

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.

Product quantity

567 units

Voluntary mandated

Voluntary: Firm initiated

City

Herlev

State

N/A

Country

Denmark

Event id

97830

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