Siemens Axiom Artis Fluoroscopic X-Ray System Recalled for Foot Switch Housing Gap
Siemens is recalling Axiom Artis fluoroscopic x-ray systems because a gap in the wireless foot switch housing could allow liquids to penetrate the interior, potentially causing the switch to fail.
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. The hazard is a potential mechanical failure of a foot switch due to liquid penetration, which is a low-risk contamination or functional defect without reported injuries or hospitalizations, fitting the Moderate criteria for voluntary precautionary recalls or minor defects.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Axiom Artis fluoroscopic x-ray system. The recall involves 2,158 units distributed in the US and 6,139 units worldwide.
The recall is due to a gap in the housing of the wireless foot switch. This gap could potentially result in liquids, such as disinfectants, cleaning agents, or bodily fluids, penetrating the interior of the switch. In rare cases, the introduction of these liquids could result in the failure of the foot switch.
Affected units are identified by Device Model 4787813 and specific serial numbers listed in the agency record. Users should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Axiom Artis fluoroscopic x-ray system
- 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.
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