Home / Brands / B-K Medical A/S
B-K Medical A/S Recalls
9 recalls on record · August 10, 2016 to November 12, 2025 · Medical Devices
Recalls by year
16
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 12, 2025Medical DevicesFDA
B-K Medical A/S recalls bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
Hazard: 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.
November 12, 2025Medical DevicesFDA
B-K Medical A/S recalls bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
Hazard: 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.
November 12, 2025Medical DevicesFDA
B-K Medical A/S recalls bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
Hazard: 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.
November 12, 2025Medical DevicesFDA
B-K Medical A/S recalls UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
Hazard: 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.
November 12, 2025Medical DevicesFDA
B-K Medical A/S recalls Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
Hazard: 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.
November 12, 2025Medical DevicesFDA
B-K Medical A/S recalls 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focu
Hazard: 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.
October 30, 2024Medical DevicesFDA
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 sy
Hazard: 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.
January 31, 2024Medical DevicesFDA
B-K Medical A/S recalls bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
Hazard: An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
August 10, 2016Medical DevicesFDA
B-K Medical A/S recalls BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The s
Hazard: In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be unaware of the calculation factor (1) and assume the generic volume calculation factor is similar to that of the other (prostate, adenoma, testis, kidney, and bladder) volume calculation factors provided in the software.