Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BK Medical ApS Ultrasound System Scanner bk2300 - Model #: Recalled by B-K Medical A/S Due to In the system (bk3500) software generic volume measurement...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact B-K Medical A/S directly.
Affected Products
BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN
Quantity: 6
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 3 states: FL, MA, TX
About B-K Medical A/S
B-K Medical A/S has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report