Siemens X-Ray Systems Software Issue May Cause Patient Misdiagnosis
Siemens Medical Solutions USA is recalling 367 mobile X-ray systems (186 Cios Flow and 181 Cios Spin) due to a software issue that may result in patient misdiagnosis and repeat radiation exposure. Affected units were distributed nationwide.
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: This is an FDA Class II medical device recall for diagnostic imaging systems. The software defect may result in patient misdiagnosis and unnecessary radiation exposure, representing a significant risk for a risk-of-harm product where no injuries have been reported to date.
Plain-English summary
Siemens Medical Solutions USA is recalling 367 mobile X-ray systems (186 Cios Flow and 181 Cios Spin, both VA30 models). These systems are used in surgical and clinical environments to provide X-ray imaging during medical procedures.
The recalled equipment has a software issue that does not meet updated requirements from DIN and IEC standards. According to the manufacturer, this defect may result in patient misdiagnosis and unnecessary repeat radiation exposure during clinical use.
The affected units were distributed nationwide. Specific serial numbers and device identifiers are detailed in the FDA recall notice.
Healthcare facilities operating these systems should contact Siemens Medical Solutions USA for information about corrective actions, such as software updates, and for guidance on system use pending remediation.
The recalled product
- Product
- ***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…
- Manufacturer
- Siemens Medical Solutions USA, Inc
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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