Agency classClass IIOur severity:High FDA (Devices)·Z-1283-2016·Announced 2016-04-06

Siemens AXIOM Artis zee/zeego X-Ray Systems Recalled for Cooling Leak

Siemens is recalling 986 AXIOM Artis zee/zeego angiography systems because a cooling system leak could 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 involves a risk-of-harm product (medical device) where a system failure could occur, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 986 AXIOM Artis zee/zeego x-ray angiographic systems. These systems are used for diagnostic imaging and interventional procedures, including cardiac and neuro angiography. The recall covers units distributed nationwide across the United States, including Puerto Rico.

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 source text does not specify instructions for consumers or healthcare providers on how to handle the recall or what to do if a system fails. Affected serial numbers are listed in the structured product information.

The recalled product

Product: AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: 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: equipment-failure
cooling-system-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 (20)

Serial Numbers: Artis Q biplane Serial # 121061
121089
121094
121006
121013
121040
121062
121082
121011
121039
121134
121053
121054
121014
121112
121051
121004
121133
121018
121036

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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