Medical Imaging System May Fail to Release X-rays Under Specific Conditions
Siemens Artis zee floor angiography systems may fail to release x-rays when the SID lift and x-ray functions are activated simultaneously, causing procedural delay. Three units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with software malfunction causing procedural delay. Source text does not report any illnesses, injuries, deaths, or serious adverse events. The hazard is operational inconvenience rather than a reported safety risk.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling Artis zee floor angiography systems with software VD12 (Model 10094135) distributed nationwide. When the SID (source-to-image distance) lift movement is activated and an x-ray is simultaneously released, the x-ray function fails to operate and displays the message "No x-ray, try again," resulting in a short delay in the procedure.
This Class II recall affects three units with serial numbers 124703, 139012, and 139023. The issue is a software malfunction that occurs only when both SID lift and x-ray functions are triggered at the same time, preventing the x-ray from being released during that specific circumstance.
Healthcare facilities operating these systems should be aware of this condition and take appropriate measures to avoid simultaneous activation of the SID lift and x-ray functions during procedures.
The recalled product
- Product
- Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 3
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)
- Serial Numbers: 124703 139012 139023
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 · software malfunction
See all →- HighAbbott Merlin pacemaker programmer may fail to terminate threshold test
FDA (Devices) · 2026-06-17
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- ModerateProtocol Configuration Tool software v1.3.0 for Hamilton AutoLys STAR
FDA (Devices) · 2026-04-29
- ModerateChange Healthcare Cardiology Hemo Software Unexpected Shutdown Risk
FDA (Devices) · 2025-07-09
- HighSiemens Interventional Fluoroscopic X-Ray System Software Communication Failure
FDA (Devices) · 2025-07-09