Agency classClass IIOur severity:High FDA (Devices)·Z-0977-2022·Announced 2022-04-27

Artis Q zeego X-ray system recalled for inadequate cooling risk

Siemens is recalling 38 Artis Q zeego X-ray systems nationwide due to a cooling circuit malfunction that may prevent adequate cooling of the X-ray tube, triggering automatic 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: This is an FDA Class II medical device recall involving a risk-of-harm scenario where inadequate cooling could compromise equipment operation. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3). No illnesses or injuries are reported in the source.

Plain-English summary

Siemens Medical Solutions USA, Inc is recalling 38 Artis Q zeego X-ray imaging systems (Model Number 10848283) due to a cooling circuit malfunction. The systems are distributed nationwide.

If the coolant level in the cooling circuit drops below a certain level, the X-ray tube may not be sufficiently cooled. The system will initially display the message 'TUBE HOT, have a break'. Several minutes later, the system will block X-ray operation and display 'NO XRAY: TUBE TOO HOT' to prevent further equipment damage.

Users of affected systems should contact Siemens Medical Solutions USA, Inc for information on remediation. Affected serial numbers and the device UDI (4056869010007) are identified in the recall notice.

The recalled product

Product: Artis Q zeego, Model Number 10848283
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Medical Imaging / Diagnostic Equipment
Hazard: inadequate-cooling
equipment-malfunction
Affected units: 38

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: 4056869010007

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 · inadequate cooling