Siemens Medical Solutions USA, Inc - Cios Flow - Class 2 Recall

The Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment and provides comprehensive image acquisition modes. It consists of a C-arm with X-ray source on one side and flat panel detector on the opposite side, as well as an image display station with a moveable trolley for the image processing and storage system, image display, and documentation. Software modifications since the predicate include system software VA30 modifications (target pointer, digital cine mode, Cios OpenApps), interactive user touch control, dose regulation indicator, new sound radiation delay, new product software security, and upgrade to Windows 10 OS. Hardware modifications include new CMOS Flat Panel Detector, wireless foot switch, optional laser light localizer green, optional cart for remote control unit, and anti-microbial coating on C-arm and trolley. Material Number: 11108110
Source: Medical Device Recalls - Category: Medical Devices Source Type: alerts