Siemens Artis Q angiography systems may fail to deliver x-ray during procedures
Siemens Artis Q angiography systems may fail to release x-ray when source-to-image distance lift and x-ray release are activated simultaneously, causing procedure delays.
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 is a Class II medical device recall with no reported injuries or illnesses. The hazard involves potential failure of x-ray delivery during critical diagnostic and interventional procedures, representing a risk-of-harm scenario in a high-risk medical context.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling Artis Q ceiling-mounted angiography systems with software version VD12 used for diagnostic imaging and interventional procedures. The recall addresses a software issue where simultaneous activation of source-to-image distance (SID) lift movement and x-ray release prevents x-ray delivery, causing the system to display a "No x-ray, try again" message and resulting in procedure delays.
This Class II recall affects 67 units distributed nationwide across the United States. The affected systems can be identified by serial numbers listed in the FDA recall notice.
Healthcare facilities currently using Artis Q systems should verify whether their equipment is affected by checking the provided serial numbers. Affected facilities should contact Siemens Medical Solutions USA, Inc. for guidance on resolving this issue.
The recalled product
- Product
- Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 67
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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 10 products in this recall →Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · equipment malfunction
See all →- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereHologic Selenia Dimensions Mammography Systems Loose Internal Bolts
FDA (Devices) · 2026-05-20
- SevereHalyard CATH LAB Kit Recalled for Syringe Adapter Disconnection Risk
FDA (Devices) · 2026-05-13
- SevereHalyard Cardiac Catheterization Tray Kits Recalled for Connection Risk
FDA (Devices) · 2026-05-13