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.
What this means for you
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
- Hazard
- software-defect
- patient-misdiagnosis
- radiation-exposure
Distribution
Distributed nationwide across the United States.
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