Device Recall BK Medical

Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277

Radiology Devices

2

No

Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia

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

Serial Numbers: 1831984 1831985 1831986 1831987 1831989 1831990 1831992 1832004 1832007 1844219 1844235 1844239 1844240 1844241 1847871 1847875 1847889

Radiology Devices

2

No

CA, CO, CT, FL, LA, GA, NJ, NY, VA, VT

Linear Array Transducer || Type: 8809