Siemens Medical Solutions USA, Inc Recall 93127
Description: 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
Siemens Medical Solutions USA, Inc Recall 93127 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0196-2024 |
| Event ID | 93127 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | MD, TN |
| Recall Reason | Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure |
| Device Classification | 20231108 |
| Device Code Info | UDI-DI: 04056869246628 S/N: 83108 |
| Center Classification Date | 20231027 |
| Recall Initiation Date | 20230912 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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