B-K Medical A/S
Country not established
- Devices
- 15
- FDA recalls
- 98 ongoing
At a glance
Market reach
- United States
- FDA recalls
What B-K Medical A/S makes
B-K Medical A/S manufactures handheld and portable ultrasound scanners, including models such as the Pro Focus (Model 2202), Mini Focus (Model 1402), and various Type 1101, 2101, 2102, and 2400 series devices. These devices are designed for diagnostic imaging in medical settings, supporting real-time visualization of internal body structures.
The company’s ultrasound scanners are classified as Class II medical devices under FDA regulations and are recorded in the 510(k) premarket notification database. The manufacturer is based in the United States.
Catalogue
Search and filter all 15 devicesFDA recalls
FDA recall records list 9 recalls initiated by B-K Medical A/S, the earliest on 2016-06-28 and the most recent on 2025-10-09. By recorded status: 8 ongoing and 1 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware and electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 1
- 2024 1
- 2025 6
- 2026 0
2025
- 9 Oct 2025 Z-0435-2026 Class II Ongoing 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.
Full distribution text
- 9 Oct 2025 Z-0436-2026 Class II Ongoing 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.
Full distribution text
- 9 Oct 2025 Z-0437-2026 Class II Ongoing 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.
Full distribution text
- 9 Oct 2025 Z-0438-2026 Class II Ongoing 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.
Full distribution text
- 9 Oct 2025 Z-0439-2026 Class II Ongoing 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.
Full distribution text
- 9 Oct 2025 Z-0440-2026 Class II Ongoing 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.
Full distribution text
- 9 Oct 2025 Z-0435-2026 Class II Ongoing 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.
2024
- 4 Sep 2024 Z-0136-2025 Class II Ongoing 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.
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- 4 Sep 2024 Z-0136-2025 Class II Ongoing 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.
2023
- 30 Nov 2023 Z-0813-2024 Class II Ongoing An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
Full distribution text
- 30 Nov 2023 Z-0813-2024 Class II Ongoing An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
2016
- 28 Jun 2016 Z-2325-2016 Class II Terminated 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.
Frequently asked questions
How many devices does B-K Medical A/S have in the registry?
The registry currently lists 15 devices for B-K Medical A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list B-K Medical A/S's devices?
Among its 15 most recently registered devices, B-K Medical A/S has devices listed in FDA 510(k) (15 devices).
What risk classes do B-K Medical A/S's devices fall under?
Among its 15 most recently registered devices, the classes recorded for B-K Medical A/S's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for B-K Medical A/S?
FDA recall records list 9 recalls initiated by B-K Medical A/S, the most recent initiated on 2025-10-09. 8 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from B-K Medical A/S in the registry?
The most recently registered devices listed for B-K Medical A/S include DIAGNOSTIC ULTRASOUND SYSTEM, TYPE 3535, MODIFIED, ULTRASOUND SCANNER 2001, K-KATH URETHRAL CATHETER INTRODUCER and ULTRASOUND SCANNER, MODEL TYPE 2101.