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.
What this means for you
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.
See all 3 products in this recall →Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · liquid penetration
See all →- ModerateSiemens Artis Zee and Zeego Fluoroscopic X-Ray System Recall
FDA (Devices) · 2017-03-22