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
Siemens is recalling Cios Flow mobile fluoroscopic X-ray systems due to a software issue that could cause patient misdiagnosis or repeat imaging. This affects specific models sold between certain dates with unique serial numbers.
The software issue in the Cios Flow systems may cause the device to misdiagnose patient conditions or require repeat imaging. This happens because the system does not properly fulfill new standards from DIN and IEC, leading to potential errors in medical imaging.
Healthcare facilities using the Cios Flow (VA30) mobile X-ray systems are most at risk. Patients undergoing imaging procedures with these systems may experience misdiagnosis or repeat exposures.
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.
Look for serial numbers starting with 80006-82207 or 83003-83515 on the device's label.
The software issue may cause patient misdiagnosis or repeat imaging due to the system not properly fulfilling new requirements from DIN and IEC standards.
Check for serial numbers starting with 80006-82207 or 83003-83515. The affected units have material numbers 11108110 for Cios Flow and 10308194 for Cios Spin.
No, but healthcare facilities should monitor for potential misdiagnosis or repeat imaging and follow the action steps to ensure safety.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0196-2024 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0196-2024 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
