Siemens Cios Alpha X-ray system software defect may cause patient misdiagnosis
Siemens Cios Alpha (VA30) C-arm X-ray systems have a software issue that may not meet updated DIN and IEC standards. This defect could result in patient misdiagnosis or unnecessary repeat imaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall for a risk-of-harm product (diagnostic imaging equipment that could cause patient misdiagnosis). No illnesses or injuries have been reported; the hazard is theoretical based on potential non-compliance with safety standards.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 237 Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray systems distributed nationwide. These devices are used in surgical environments for fluoroscopic imaging.
The recall is due to a software issue. The software in the affected systems does not fulfill new requirements from DIN and IEC standards applicable to Cios VA30 systems. The defect may result in patient misdiagnosis or unnecessary repeat radiation exposure during imaging procedures.
Healthcare facilities using affected systems should contact Siemens Medical Solutions USA, Inc. for software updates or guidance on remediation steps to ensure compliance with the updated standards.
The recalled product
- Product
- Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 237
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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