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RecallWatchMedical Device Safety
Class IIOngoingZ-0439-2026

B-K Medical A/S recalls bk3500 Ultrasound System w/battery

B-K Medical A/SHerlev, DenmarkReported Nov 12, 2025 · 8 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic

Lot / code information

GTIN
05704916000264 and pending
Serial #
5009743, 5009345, 5009346, 5009353, 5007595, 5007746 — +118 moreShow all
5009743, 5009345, 5009346, 5009353, 5007595, 5007746, 5009358, 5009726, 5009021, 5008627, 5008542, 5008280, 5008994, 5007594, 5008019, 5009344, 5009000, 5009001, 5009002, 5009339, 5009340, 5009722, 5013052, 5013067, 5008617, 5007733, 5009361, 5008995, 5009357, 5008012, 5009732, 5006923, 5007592, 5009019, 5009723, 5009729, 5009003, 5009005, 5008271, 5009730, 5007422, 5009747, 5007424, 5008265, 5008534, 5009012, 5009740, 5008541, 5006928, 5009737, 5009347, 5009348, 5009349, 5009363, 5009720, 5008625, 5009733, 5009360, 5009013, 5009014, 5007429, 5007742, 5009719, 5013351, 5009011, 5009017, 5009727, 5013069, 5008262, 5009020, 5007850, 5009335, 5009336, 5007609, 5009004, 5007608, 5007857, 5009338, 5009725, 5009351, 5009724, 5008147, 5009350, 5009352, 5008623, 5009738, 5008996, 5008274, 5013610, 5009341, 5013591, 5009742, 5008551, 5009741, 5008053, 5008269, 5008018, 5008267, 5009010, 5009739, 5013423, 5007426, 5007611, 5007855, 5009745, 5009734, 5007738, 5008533, 5008014, 5008270, 5008536, 5009007, 5008545, 5008281, 5009342, 5009343, 5009728, 5009735, 5009736, 5009746, 5013319, 5013325, 5013586, 5008626

What the firm 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 bksupport.us@gehealthcare.com or your local Service Representative.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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