Siemens Cios Alpha and Spin Mobile X-Ray Systems Recalled for Electrical Malfunction
Siemens is recalling Cios Alpha and Cios Spin mobile X-ray systems because a hardware error could cause permanent loss of imaging functionality.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a loss of functionality rather than direct physical injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling specific models of Cios Alpha and Cios Spin mobile X-ray systems. The affected models include Cios Alpha (VA20) Model 10308191, Cios Alpha (VA30) Model 11105200, and Cios Spin (VA30) Model 10308194. These systems are designed to provide X-ray imaging of anatomical structures during clinical applications.
The recall is due to a hardware error involving the Hot Plugging feature. This feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator, which is part of the main unit (c-arm). This malfunction may result in a permanent loss of imaging functionality.
The recall covers 282 units in the United States and 1,363 units outside the US, distributed nationwide. Affected serial numbers are listed in the source data. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address this issue.
The recalled product
- Product
- Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
- Manufacturer
- Siemens Medical Solutions USA, Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- S-N Affected systems: 10xxx: 10001
- 10003
- 10010 10027
- 10029 10031
- 10033 10040
- 10042 10045
- 10048 10052
- 10054 10110
- 10112 10119 11xxx: 11000 11004
- 11006 11028
- 11030 11101
- 11103 11183
- 11185 11205
- 11207 11372
- 11374 11387
- 11600 11608 12xxx: 12000 12014
- 12016 12024
- 12026 12045
- 12047 12052
- 12054
Distribution
Distributed nationwide across the United States.
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