Z-0438-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 12, 2025
- Initiation Date
- October 9, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 496 units
Product Description
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
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.
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.
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.