Agency classClass IIOur severity:High FDA (Devices)·Z-0967-2022·Announced 2022-04-27

Artis zee floor X-ray systems recalled for cooling system failure

Siemens is recalling 305 Artis zee floor X-ray imaging systems because the cooling circuit may fail to maintain adequate coolant levels, potentially causing the X-ray tube to overheat. The system includes automatic safeguards that shut down X-ray operation if overheating is detected.

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: This recall meets the Score 3 (High) criterion as a Class II risk-of-harm product with no reported injury or illness. The cooling system defect poses a risk of X-ray tube overheating, but the device's automatic safety shutdown prevents further damage and mitigates the immediate risk of harm.

Plain-English summary

Siemens Medical Solutions is recalling 305 Artis zee floor X-ray imaging systems (Model 10094135) distributed nationwide. The affected units are identified by specific serial numbers provided by the manufacturer.

The cooling circuit in these systems may fail to maintain adequate coolant levels. If the coolant level drops below the required threshold, the X-ray tube will not be sufficiently cooled, causing it to overheat. When overheating occurs, the system displays a warning message ("TUBE HOT, have a break") and after several minutes automatically blocks X-ray operation and displays a second message ("NO XRAY: TUBE TOO HOT") to prevent further equipment damage.

Healthcare facilities using this equipment should verify their unit's serial number against the recall list. If your system is affected, contact Siemens Medical Solutions for instructions on service or replacement. Do not operate the system if you suspect a cooling system malfunction.

The recalled product

Product: Artis zee floor, Model Number 10094135
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — X-ray Imaging Equipment
Hazard: cooling-system-failure
equipment-overheating
Affected units: 305

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: 4056869010045

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 system failure