Siemens Medical Solutions Recalls Artis Q and Q.Zen Angiography Systems
Siemens Medical Solutions is recalling Artis Q and Q.Zen angiography systems because biomass 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, and the source text describes a potential mechanical defect (pump damage) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the ARTIS Q and Q.ZEN Modular Angiographic Systems. These are interventional fluoroscopic x-ray systems used for diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography.
The recall is due to the possibility that contaminants, in the form of biomass, may develop in the cooling system of the Artis systems. This development can result in damage to the pump system.
The recall affects 11,111 units worldwide, including 3,187 units in the United States. The affected units 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 Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 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 includi
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
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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