Agency classClass IIOur severity:High FDA (Devices)·Z-0979-2022·Announced 2022-04-27

Siemens Artis Q.zen ceiling system recall: inadequate X-ray tube cooling risk

Siemens recalls 81 Artis Q.zen ceiling imaging systems distributed nationwide due to risk of inadequate X-ray tube cooling if coolant levels fall below a critical threshold, potentially triggering system shutdown.

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: FDA Class II medical device recall with no reported injuries or illnesses. The hazard presents a risk of equipment malfunction if coolant levels drop below the required threshold, causing inadequate X-ray tube cooling. Meets the criterion 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Siemens Medical Solutions USA, Inc. issued a recall for the Artis Q.zen ceiling, Model Number 10848354. The recall affects 81 systems with specific serial numbers that were distributed nationwide in the United States.

The X-ray imaging system's cooling circuit may allow coolant levels to drop below the minimum threshold required for adequate X-ray tube cooling. When coolant falls below this threshold, the X-ray tube becomes insufficiently cooled. The system displays a warning message stating 'TUBE HOT, have a break.' If the coolant level does not recover, the system automatically blocks X-ray emission and displays 'NO XRAY: TUBE TOO HOT' to prevent further damage to the X-ray tube.

Affected systems can be identified by serial number as listed in the FDA recall documentation.

The recalled product

Product: Artis Q.zen ceiling, Model Number 10848354
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging System
Hazard: cooling-failure
equipment-overheating
Affected units: 81

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: 4056869010021

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