Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0971-2022·Announced 2022-04-27

X-Ray Imaging System Cooling Circuit Failure Recall

Siemens is recalling Artis zee floor MN X-ray systems due to a potential cooling circuit malfunction. If coolant drops below adequate levels, the X-ray tube may not cool properly and the system will automatically shut down.

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: This is an FDA Class II recall with no reported illnesses or injuries. The system includes automatic safeguards that prevent X-ray operation when cooling becomes insufficient, and the recall is precautionary in nature.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the Artis zee floor MN imaging system, Model Number 10094142. Twenty-four units were distributed nationwide.

The cooling circuit in these systems may drop below adequate coolant levels, resulting in insufficient cooling of the X-ray tube. When this occurs, the system displays the message 'TUBE HOT, have a break' as a warning. If the cooling system does not recover within several minutes, the system automatically blocks X-ray operation and displays the message 'NO XRAY: TUBE TOO HOT' to prevent further equipment damage.

Facilities should verify their equipment serial numbers against the recall notice and contact the manufacturer for corrective action instructions.

The recalled product

Product: Artis zee floor MN, Model Number 10094142
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — X-ray imaging system
Hazard: cooling-failure
Affected units: 24

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)

UDI: 4056869010090

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 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 14 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →

Moderate
ARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
High
ARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
Moderate
ARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
High
ARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
High
ARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10

Same hazard · cooling failure