X-ray imaging system hardware defect may prevent operation
Siemens is recalling certain X-ray imaging systems due to a potential hardware issue with the error detection mechanism. In rare cases, this could prevent X-ray emission until system shutdown.
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: This is a FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a potential failure of the error detection mechanism in rare cases, making it a precautionary recall. FDA Class II without hospitalization reports and no reported harm corresponds to Moderate severity.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling certain serial numbers of Artis imaging systems (Artis Q, Artis Q.zen, Artis pheno, and Artis icono models) due to a potential hardware issue affecting X-ray tubes.
The issue involves the error detection mechanism. In rare cases, if this mechanism fails, the system will not be able to release X-rays until the equipment is shut down and restarted.
The recall affects 1,389 units total: 590 distributed in the United States and 799 distributed internationally to dozens of countries including the United Kingdom, Canada, Germany, France, Japan, and China. Specific serial numbers have been identified for this recall.
The recalled product
- Product
- Artis pheno- Model No. 10849000
- Manufacturer
- Siemens Medical Solutions USA, Inc
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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.
See all 3 products in this recall →Related recalls
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Similar recalls
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FDA (Devices) · 2019-07-10
- HighSiemens Artis Q X-ray Systems Recalled for Potential Tube Breakdown
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