Siemens Recalls Cios Alpha Mobile X-Ray Systems Due to Software Issues
Siemens Medical Solutions is recalling 89 Cios Alpha mobile X-ray systems due to software issues. The units were distributed nationwide to 30 states.
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: The recall is classified as FDA Class II, which typically indicates a reasonable probability of temporary or medically reversible adverse health consequences. The source text does not report any injuries or illnesses, placing this in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 89 Cios Alpha mobile X-ray systems (Model # 10308191) due to software issues. The recall is classified as Class II by the U.S. Food and Drug Administration.
The affected systems were distributed nationwide to the states of AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, and WI. The source text does not specify the exact nature of the software issues or the potential impact on patient safety or device functionality.
Healthcare facilities and users of these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the software issues. The source text does not provide specific remediation steps or a timeline for the recall.
The recalled product
- Product
- Cios Alpha, mobile X-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 89
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)
- Model # 10308191
Distribution
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