The Recall Desk
ModerateFDA (Devices)·Z-3092-2017·Announced 2017-09-06

Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US because a cooling system leak could cause equipment failure.

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 involves equipment failure due to a cooling leak, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving potential malfunction without reported harm.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 986 units of the AXIOM Artis zee/zeego and Artis Q/Q.zen x-ray angiographic systems 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 a potential leak in the cooling system. If the leak occurs, fluids could seep into the equipment cabinet. Loss of coolant can result in cooling system failure and subsequent system failure. The source notes that this leak can occur sporadically in affected systems.

The affected units are distributed nationwide. Specific serial numbers for the Artis zee biplane systems are listed in the recall documentation. Siemens is the recalling firm.

The recalled product

Product
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients.
Affected units
986

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 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 12 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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