Siemens Cios Alpha Mobile X-ray System Recalled for Component Wear
Siemens is recalling 257 Cios Alpha mobile X-ray systems because continuous high-output use may cause premature failure of radiation components.
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 2/5 (Moderate).
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, but the source text does not report any injuries, illnesses, or deaths, and the hazard is a functional failure (loss of imaging) rather than a direct physical injury risk.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 257 units of the Cios Alpha mobile X-ray system, Model Number 10308191. The recall is due to a risk of premature failure of the Monoblock and loss of imaging X-rays.
The defect occurs when the system is operated continuously at very high tube output, specifically when tube voltages of 125 kV are used for 30 minutes or more. This continuous operation can result in increased wear of the radiation-emitting components.
The affected units were distributed nationwide in the United States, including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- Cios Alpha, Model Number 10308191 Mobile X-ray system - 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 are not limited to…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 257
Distribution
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