← Every firm
B-K Medical A/S FDA Recalls
8 recalls on file across devices, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, UltrasonicClass IIOct 9, 2025GE HealthCare has become aware that the Instructions for Use |
| bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, UltrasonicClass IIOct 9, 2025GE HealthCare has become aware that the Instructions for Use |
| Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, UltrasonicClass IIOct 9, 2025GE HealthCare has become aware that the Instructions for Use |
| 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex FocuClass IIOct 9, 2025GE HealthCare has become aware that the Instructions for Use |
| bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, UltrasonicClass IIOct 9, 2025GE HealthCare has become aware that the Instructions for Use |
| bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, UltrasonicClass IIOct 9, 2025GE HealthCare has become aware that the Instructions for Use |
| bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound syClass IISep 4, 2024The internal power connections at the power inlet of the ult |
| bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.Class IINov 30, 2023An issue on the Dual Live Compare feature on the bkActiv sys |