Artis zeego X-ray imaging system recalled for insufficient cooling
Siemens is recalling 183 Artis zeego X-ray imaging systems due to a cooling system defect that may prevent adequate X-ray tube cooling, triggering automatic system shutdown.
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: FDA Class II medical device recall with no reported illnesses or injuries. The hazard is inadequate X-ray tube cooling that triggers automatic system shutdown. This is a risk-of-harm product where injury has not yet been reported, corresponding to High severity per the rubric.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 183 Artis zeego X-ray imaging systems (Model 10280959) distributed nationwide in the United States.
If the coolant level in the cooling circuit drops below required levels, the X-ray tube may not be adequately cooled. When this occurs, the system initially displays 'TUBE HOT, have a break' and subsequently blocks X-ray operation with a 'NO XRAY: TUBE TOO HOT' message to prevent further equipment damage.
Affected units can be identified by the UDI 4056869010083 and specific serial numbers listed in the FDA recall notice. Healthcare facilities should verify the serial numbers of their equipment against the recall list provided.
Users should contact Siemens Medical Solutions USA, Inc. for instructions on remediation or corrective actions for affected systems.
The recalled product
- Product
- Artis zeego, Model Number 10280959
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- cooling-circuit-failure
- 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: 4056869010083
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