Herlev, N/A, Denmark
B-K Medical A/S recalls
3 recalls recorded since 2018, most recently on 9 October 2025. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 October 2025
- Reason
- 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
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0436-2026, Z-0440-2026, Z-0437-2026, Z-0435-2026, Z-0438-2026, Z-0439-2026
- Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
- bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
- UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
- 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
- bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
- bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
Ongoing Class II Medical devices
- Recall started
- 4 September 2024
- Reason
- The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.
- Distribution
- Worldwide - US Nationwide - There was also government/military distribution and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, India, Indonesia, Ireland, Israe
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0136-2025
- bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
Ongoing Class II Medical devices
- Recall started
- 30 November 2023
- Reason
- An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
- Distribution
- US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, ID, IL, KS, MA, MD, MI, MO, NC, NE, NJ, NY, OH, PA, RI, SC, TX, UT, VA, WA, WI, and WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0813-2024
- bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.