B-K Medical A/S recalls
3 official recalls and safety alerts involving B-K Medical A/S since 2024-01, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with B-K Medical A/S or the relevant agency.
- 2025-11-12
USB-K Medical A/S recalls Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
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…
FDA · DeviceB-K Medical A/SWorldwide distribution: US (nationwide) and OUS (foreign) to countries of:…Official notice →- 2024-10-30
- US
B-K Medical A/S recalls bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery…
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.
FDA · DeviceB-K Medical A/SWorldwide - US Nationwide - There was also government/military distribution…Official notice → - 2024-01-31
- US
B-K Medical A/S recalls bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
FDA · DeviceB-K Medical A/SUS Nationwide distribution including in the states of AL, AZ, CA, FL, GA, ID,…Official notice →