Agency classClass IIOur severity:Moderate FDA (Devices)·Z-3097-2017·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 due to a cooling system leak that can cause equipment failure.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, which is a functional defect rather than a direct physical injury or high-risk pathogen, fitting the Moderate criteria for low-risk contamination or functional issues without reported injury.

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 angiography systems in the United States. These dedicated angiography systems are used for diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography.

The recall is due to a leak in the cooling system that can cause fluids to 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 were distributed nationwide. Specific serial numbers for the Artis zee multi-purpose models are listed in the structured product information. 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…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Angiography System
Hazard: cooling-leak
equipment-failure
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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