Use cautionMedical device recall · FDA · Published September 12, 2023
Siemens Cios Flow X-ray System Recall: Software Issue May Cause Patient Misdiagnosis
Siemens recalls Cios Flow mobile X-ray systems with software issue that may lead to patient misdiagnosis or repeat imaging. Affected units have specific serial numbers and material numbers.
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
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Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
“Siemens Cios Flow X-ray System Recall: Software Issue May Cause Patient Misdiagnosis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57327-siemens-cios-flow-x-ray-system-recall-software-issue-may. Based on FDA recall #Z-0196-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0196-2024%22&limit=1).
The FDA announced on Sept. 12, 2023, that Siemens Medical Solutions USA, Inc. is recalling Cios Flow and Cios Spin mobile fluoroscopic C-arm X-ray systems due to a software issue that may result in patient misdiagnosis or repeat exposure. Owners should contact Siemens for a remedy.
How to tell if you have it
Brand: Siemens
Product: Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System, Material Number 11108110
Product: Cios Spin mobile x-ray system, Material Number 10308194
Cios Flow UDI-DI: 04056869246628, Serial Numbers: 80006-80081, 82010-82239, 83003-83515
Cios Spin UDI-DI: 04056869153506, Serial Numbers: 50030-50444, 52008-53224
Distribution: Nationwide
The hazard
A software issue in the Cios Alpha, Cios Flow, and Cios Spin VA30 systems may fail to fulfill new requirements from DIN and IEC standards. This failure could result in patient misdiagnosis or repeat exposure.
Context
GovInfoNow's records show Siemens Medical Solutions USA, Inc. has had 182 other recalls on record since June 6, 2017. Other recent recalls of similar products include the Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), the Siemens ARTIS Icono Biplane Recall (May 20, 2026), and the Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include the Philips Allura Cardio Vascular-Allura Centron X-Ray System Recall (June 17, 2026), the Philips Azurion System Software R3.1 May Cause Imaging Loss recall (Dec. 12, 2025), and the Philips Incisive CT Recall (Dec. 3, 2025).
How to tell if you have this one
Check for serial numbers starting with 80006-82207 or 83003-83515 in the product's identification. The system was sold with specific material numbers: 11108110 for Cios Flow and 10308194 for Cios Spin.
Brand
Siemens
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0196-2024 (September 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0196-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.