Siemens AXIOM Artis Angiography Systems Recalled for Cooling System Contamination
Siemens is recalling AXIOM Artis angiography systems because biomass contamination 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 without reporting any patient injuries, illnesses, or deaths. This aligns with the 'Moderate' criteria for low-risk issues or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the AXIOM Artis Modular Angiography System, including the Artis zee/zeego and Artis Q/Q.zen models. The recall involves 11,111 units worldwide, with 3,187 units distributed in the United States. These systems are 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 affected devices. This contamination can result in damage to the pump system. The affected units were distributed nationwide to all 50 states, the District of Columbia, Puerto Rico, and Guam.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the potential cooling system contamination and pump damage.
The recalled product
- Product
- AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, 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, pe
- 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.
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