Ultrasound System 2300 (B-K Medical) – Battery Replacement Warning (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
Brand
B-K Medical A/S Mileparken 34 Herlev Denmark
Lot Codes / Batch Numbers
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.
Products Sold
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.
B-K Medical A/S Mileparken 34 Herlev Denmark is recalling UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultr due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
GE Healthcare issued an "URGENT MEDICAL DEVICE CORRECTION NOTICE" to its consignees on 10/09/2025 via traceable means. The notice explained the issue, potential risk, and requested: "Actions to be taken by Customer / User You can continue to use your device by following the instructions below: 1. Review and follow the applicable addendums to the Instructions for Use and the updated Service Manuals. The Addendums and Service Manuals are available for download at: https://www.gehealthcare.com/support/manuals. 2. Follow the conditions defined within the addendum and Service Manual applicable to your product for further instructions. 3. Place the applicable addendum and Service Manual with your existing product Instructions for Use. 4. If you have difficulty accessing the documentation or require a printed copy of the applicable addendum or Service Manual, please contact a GE HealthCare Service Representative for assistance. Please ensure all potential users in your facility are made aware of this safety notification and the required actions. Please retain this document for your records." For questions or concerns regarding this notification, please contact GE HealthCare at 1-800-645-4442 or bksupport.us@gehealthcare.com or your local Service Representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026