bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- B-K Medical A/S
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0438-2026
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