Siemens Axiom Artis C-arm Systems Recalled for Incorrect Channel Nuts
Siemens Medical Solutions USA is recalling 178 Axiom Artis C-arm angiographic x-ray systems because third-party installers may have used incorrect channel nuts.
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 hospitalizations, injuries, or deaths. The hazard involves incorrect hardware installation, which is a potential defect without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 178 Axiom Artis C-arm angiographic x-ray systems. The recall was initiated after the firm became aware of a potential issue where systems installed by a third-party installer may have been fitted with incorrect channel nuts.
The affected units were distributed in the United States, specifically in Pennsylvania, New Jersey, the District of Columbia, Virginia, Maryland, and Delaware. The recall covers multiple model numbers, including 10281163, 10281013, and 10280959.
The source text does not specify the exact corrective action or instructions for consumers or healthcare facilities. No injuries or illnesses have been reported in the provided text.
The recalled product
- Product
- Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 178
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 (20)
- Multiple Model numbers: 10281163
- 10281013
- 10280959
- 10272410
- 10094200
- 10094142
- 10094141
- 10094139
- 10094137
- 10094135
- 10093961
- 10093902
- 8890415
- 8890407
- 8627718
- 8395431
- 8395415
- 8395399
- 8395381
- 7728392
Distribution
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