Recall Z-2325-2016 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
B-K Medical A/S
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, Vascula
| Date | Jun 28, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | BK Medical sent an Important Corrective Action Notification letter dated June 27, 2016, to all affected customers. The letter explains the issue and asks customers to discontinue the use of the generic volume measurement and contact BK medical ApS Service for assistance. Customers with questions were instructed to call 800-645-4442. |
| Quantity | 6 |
| Distribution | Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia |
| FDA record | Open on fda.gov |