UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
Enforcement
- Recall Number
- Z-0437-2026
- Event ID
- 97830
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- B-K Medical A/S
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 12, 2025
- Initiation Date
- October 9, 2025
- Classification Date
- November 6, 2025
- Address
- Mileparken 34, N/A, Herlev, N/A, N/A, Denmark
Description
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
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.
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.
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.
567 units