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bk3000 Ultrasound System w/battery recallZ-0438-2026 · B-K Medical A/S · initiated Oct 9, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from B-K Medical A/S or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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 [email protected] or your local Service Representative.

Recall details

Recall number
Z-0438-2026
Status
Open, Classified
Initiated by the company
Oct 9, 2025
Posted by the FDA
Nov 6, 2025
Recalling firm
B-K Medical A/S
Quantity
496 units
Product code
IYN
FDA submissions
K223830
Distribution
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.

Product description

bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

Code information (models, lots, serial numbers)

Show the full code information (5k characters)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 97830).

Sources and updates

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