PlainRecalls
FDA Devices Moderate Class II Ongoing

***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

Reported: November 8, 2023 Initiated: September 12, 2023 #Z-0196-2024

Product Description

***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

Reason for Recall

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

Details

Units Affected
***Updated 12/4/23*** 186 units Cios Flow, 181 units Cios Spin
Distribution
Nationwide
Location
Malvern, PA

Frequently Asked Questions

What product was recalled? ▼
***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. Recalled by Siemens Medical Solutions USA, Inc. Units affected: ***Updated 12/4/23*** 186 units Cios Flow, 181 units Cios Spin.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 8, 2023. Severity: Moderate. Recall number: Z-0196-2024.

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