Siemens Recalls Cios Alpha and Spin X-Ray Systems for Hardware Error
Siemens is recalling 329 Cios Alpha and Cios Spin mobile X-ray systems due to a hardware error affecting the X-ray generator after a previous repair.
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, which indicates a situation where use of the product could cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries, illnesses, or fatalities, placing it in the High severity category rather than Severe or Critical.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 329 units of the Cios Alpha and Cios Spin mobile X-ray systems. These devices are designed to provide X-ray imaging of anatomical structures during clinical applications. The recall involves specific model codes: Cios Alpha (VA20) with code 10308191 and Cios Alpha (VA30) with code 11105200.
The recall is being conducted because Siemens identified a hardware error that affects the Cios Spin and Cios Alpha systems. This error specifically impacts the devices following a previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU). The agency has classified this recall as Class II.
The affected units were distributed in the United States to the states of North Carolina, Nebraska, Illinois, Texas, Ohio, Florida, Wisconsin, Minnesota, Maryland, South Carolina, California, New York, Virginia, Oklahoma, and Arizona. Healthcare facilities and users should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the repair or replacement of these devices.
The recalled product
- Product
- Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The 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
- Hazard
- Affected units
- 329
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 (VA20)- 10308191 Cios Alpha (VA30)- 11105200
Distribution
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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