Medical device X-ray imaging system recalled for cooling failure
Siemens Medical Solutions is recalling its Artis Q.zen X-ray imaging system due to a coolant circulation defect that may cause insufficient tube cooling and 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: Rated as High (Score 3) per the rubric for risk-of-harm products. This is an FDA Class II recall involving cooling system failure that could result in insufficient X-ray tube cooling. The device includes automatic safety mechanisms to prevent continued operation at critical temperatures.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Artis Q.zen floor X-ray imaging system, Model Number 10848353. The recall affects 33 systems that were distributed nationwide in the United States.
If the coolant level in the cooling circuit drops below a certain level, the X-ray tube may not be sufficiently cooled. When insufficient cooling occurs, the system displays the message "TUBE HOT, have a break." If cooling remains inadequate, the system will block X-ray operation and display "NO XRAY: TUBE TOO HOT" to prevent further damage to the equipment.
The recalled product
- Product
- Artis Q.zen floor, Model Number 10848353
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 33
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: 4056869010014
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 →Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · inadequate cooling
See all →- HighJohnson & Johnson Irrigation Sleeve Recalled for Manufacturing Defect
FDA (Devices) · 2024-05-08
- HighX-ray Imaging System May Fail to Cool Tube Properly
FDA (Devices) · 2022-04-27
- HighArtis Q zeego X-ray system recalled for inadequate cooling risk
FDA (Devices) · 2022-04-27
Similar recalls
- HighSiemens Artis X-ray systems cooling malfunction may halt procedures
FDA (Devices) · 2024-04-24
- HighX-Ray Imaging System X-Ray Tube Hardware Defect Worldwide Recall
FDA (Devices) · 2022-09-07
- HighSiemens Artis Zee and Zeego X-ray Systems Recalled for Cooling Hose Leak
FDA (Devices) · 2018-12-12
- HighSiemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak
FDA (Devices) · 2017-09-06
- HighSiemens AXIOM Artis zee/zeego X-Ray Systems Recalled for Cooling Leak
FDA (Devices) · 2016-04-06
- ModerateSiemens Artis Q X-Ray Systems Recalled for Temperature Control Defect
FDA (Devices) · 2018-09-26