Siemens Artis zee X-Ray System Recalled for Cabling Abrasion
Siemens Medical Solutions is recalling 772 Artis zee ceiling-interventional Fluoroscopic X-Ray Systems due to increased cabling abrasion that may limit functionality and disrupt clinical treatment.
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. The hazard is a functional defect leading to treatment disruption rather than direct physical harm, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 772 units of the Artis zee ceiling-interventional Fluoroscopic X-Ray System (Model Number: 10094137) in the United States. The recall is due to increased abrasion of the cabling at the cable outlet of the inner C-arm. This defect may result in limited functionality that is insufficient to continue with treatment as planned.
The affected systems were distributed nationwide. The source text does not report any specific injuries, illnesses, or deaths associated with this defect. The primary risk is the potential cancellation of clinical treatment or the need to continue treatment on an alternative system due to the equipment's limited functionality.
Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. Siemens Medical Solutions is the recalling firm responsible for addressing the issue.
The recalled product
- Product
- Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 772
Distribution
Distributed nationwide across the United States.
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