Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0980-2022·Announced 2022-04-27

Artis Q.zen Biplane X-ray Systems Coolant Level Failure Recall

Siemens is recalling 69 Artis Q.zen biplane systems where coolant levels may drop sufficiently to prevent adequate X-ray tube cooling, triggering automatic shutdown safeguards.

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. Although the system involves medical imaging equipment, it has built-in safeguards that automatically prevent continued operation when cooling is insufficient. This qualifies as a voluntary precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 69 Artis Q.zen biplane imaging systems (Model Number 10848355) that may experience cooling circuit failures. The defect involves inadequate coolant levels that could prevent proper cooling of the X-ray tube.

When the coolant level drops below a critical threshold, the X-ray tube may not be sufficiently cooled. The system displays a warning message ("TUBE HOT, have a break") to alert users. Within minutes, if the condition persists, the system automatically blocks X-ray operation and displays "NO XRAY: TUBE TOO HOT" to prevent further equipment damage.

This recall affects 69 systems distributed nationwide. Facilities operating affected serial numbers should monitor coolant levels and ensure proper maintenance. Contact Siemens Medical Solutions USA, Inc. immediately if you operate an affected unit. The automatic safeguards prevent continued X-ray operation when cooling is insufficient, but users should follow manufacturer guidance for service and coolant level checks.

The recalled product

Product: Artis Q.zen biplane, Model Number 10848355
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — X-ray Imaging Equipment
Hazard: cooling-system-failure
overheating
equipment-malfunction
Affected units: 69

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: 4056869010038

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

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