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.
What this means for you
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
- Hazard
- cooling-system-failure
- equipment-overheating
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.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03