Device Recall BK Medical ApS Ultrasound System Scanner

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