Recall Z-0196-2024 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110 (2)Cios Spin- a mobile x-ray system designed to provide x-ray imaging of the anatomical structures of patients during clinical applications Material Number: 10308194
| Date | Oct 27, 2023 (initiated Sep 12, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Software design |
| Action | Siemens Medical Solutions USA issued Urgent Medical Device Correction Letter (AX035/23/S).Letter states reason for recall, health risk and action to take. Siemens will correct the software error via Update Instruction AX036/23/S. With software version VA30K, the user interface of Cios VA30 systems will be changed to consider the current standards DIN 6862-3 and IEC 60601-2-54. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, |
| Quantity | ***Updated 12/4/23*** 186 units Cios Flow, 181 units Cios Spin |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |