Agency classClass IIOur severity:High FDA (Devices)·Z-3091-2017·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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of equipment failure during medical procedures, which fits the rubric for high-risk products where injury has not yet been reported.

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 leak in the cooling system that allows fluids to seep into the equipment cabinet. This loss of coolant can result in cooling system failure and subsequent system failure. The leak can occur sporadically in affected systems.

The affected units are identified by specific serial numbers for the Artis Q.zen floor model: 105007, 105018, 105016, and 105017. The recall is classified as Class II by the FDA. Users should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the defect.

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 Systems
Hazard: equipment-failure
cooling-leak
Affected units: 986

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 (1)

Artis Q.zen floor- Serial number: 105007 105018 105016 105017

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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