Siemens X-ray System Fan Wear May Cause Equipment Malfunction
Siemens is recalling 88 Artis Icono X-ray systems in the U.S. due to increased fan wear that could lead to electrical failure and malfunction of the imaging system during operation.
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: FDA Class II recall with no reported hospitalizations, injuries, or adverse events. The hazard is a theoretical electrical failure in medical equipment based on observed fan wear during testing. Per the rubric, Class II recalls without reported harm and purely theoretical hazards are classified as moderate.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Artis Icono Interventional Fluoroscopic X-Ray System, Model No. 11327600. The company has identified 88 units in the United States and 195 units worldwide affected by this issue.
During system tests, increased wearing of the image acquisition system fans was observed. This wear could lead to electrical failure, which may cause malfunction of the imaging system during regular operation. No adverse events or injuries have been reported to date.
Healthcare providers using affected equipment should contact Siemens Medical Solutions USA, Inc. for servicing and guidance. Patients and providers should not discontinue use without consulting with Siemens or their medical device representative.
The recalled product
- Product
- Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
- Manufacturer
- Siemens Medical Solutions USA, Inc
Distribution
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