BK Medical ApS Ultrasound System Scanner bk2300 — Class II medical device recall Z-2325-2016
Terminated recall by B-K Medical A/S, reported 2016-08-10, distributed in FL, MA, TX. In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be unaware of the c
| Recall number | Z-2325-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B-K Medical A/S, Herlev, Denmark |
| Recall initiated | 2016-06-28 |
| Classified | 2016-08-03 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2016-08-29 |
| Distributed | FL, MA, TX |
| Countries outside the US | AU |
| Quantity | 6 |
| Reason classes | software |
| Serial numbers | 5007596, 5007734, 5007742, 5007750, 5008004, AND50074277 |
| Model numbers | BK3500 |
Product
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2325-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.