B-K Medical A/S
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
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.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →