Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2393-2016·Announced 2016-08-17

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.

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, 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…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Angiography System
Hazard: contamination
mechanical-failure

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

Distributed nationwide across the United States.

The notice also names 52 states specifically:

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.

See all 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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