FDA Device recall Z-2325-2016
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…
- FDA Device
- Class II
- terminated
- Published 2016-08-10
On 2016-08-10 the FDA classified a Class II recall of 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… by B K Medical A S, citing 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 facto….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2325-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-28 |
| Published | 2016-08-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | B K Medical A S |
| Distribution | FL, MA, TX |
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
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.
Identifiers
| code_info | Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2325-2016%22
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