Siemens AXIOM Artis X-Ray Systems Recalled for Cooling System Contamination
Siemens is recalling AXIOM Artis angiography systems because biomass contaminants in the cooling system may damage the pump.
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, but the source text describes a mechanical defect (pump damage) caused by contamination rather than a direct patient safety hazard like injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling AXIOM Artis, Artis zee / zeego, and Artis Q/ Q.zen angiography systems. These are dedicated x-ray systems used for diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography.
The recall is due to the possibility of contaminants, specifically biomass, developing in the cooling system of the devices. This contamination can result in damage to the pump system.
The recall affects 3,187 units in the United States and 11,111 units worldwide. The devices were distributed nationwide to all 50 states, the District of Columbia, Puerto Rico, and Guam. Affected model numbers include 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959, 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355, 5904433, 5904441, 5904466, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728350, and 7728392.
The recalled product
- Product
- ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese p
- Manufacturer
- Siemens Medical Solutions USA, Inc
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)
- Model Numbers:10094135
- 10094137
- 10094139
- 10094141
- 10094142
- 10094143
- 10280959
- 10848280
- 10848281
- 10848282
- 10848283
- 10848353
- 10848354
- 10848355
- 5904433
- 5904441
- 5904466
- 5904649
- 5904656
- 5917054
Distribution
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 · contamination
See all →- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02