Siemens Cios Alpha C-arm X-ray System Recalled for Component Wear
Siemens is recalling two Cios Alpha mobile X-ray systems because continuous high-output operation may cause premature failure of radiation components.
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (loss of imaging) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling two units of the Cios Alpha mobile C-arm X-ray system (Material # 11105200) with software version VA30. The recall is due to a risk of increased wear on radiation-emitting components during continuous operation at high tube outputs.
This wear may result in the premature failure of the Monoblock and a loss of imaging X-rays. The affected devices were distributed in North Carolina and Massachusetts.
Healthcare facilities should stop using the affected units and contact Siemens Medical Solutions USA, Inc. for further instructions on the recall.
The recalled product
- Product
- Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but a
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 2
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 (1)
- Cios Alpha system with SW VA30
Distribution
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