Recall Z-2325-2016— B-K Medical A/S
Class II · Terminated
Class II FDA medical device recall by B-K Medical A/S, initiated 2016-06-28, terminated 2016-08-29. It names 4 FDA 510(k) clearances: K151910, K152052, K143298 and 1 more. 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..
- Recalling firm
- B-K Medical A/S
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-28
- Terminated
- 2016-08-29
- Firm location
- Herlev, Denmark
510(k) clearances named in this recall
4 on FDA's record- K151910 — Ultrasound Scanner System BK2300
- K152052 — Ultrasound Scanner System bk2300
- K143298 — Ultrasound Scanner System bk2300
- K140428 — ULTRASOUND SCANNER SYSTEM BK2300
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.