Siemens Artis Q.zen Angiography System May Fail to Fire X-rays During Simultaneous Operations
Three Siemens Artis Q.zen angiography systems may fail to fire X-rays when the source-to-image distance lift is activated simultaneously with X-ray commands. This causes a procedural delay.
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 device without reported hospitalizations or injuries. The stated consequence is a short procedural delay when specific operational conditions occur simultaneously. No deaths or serious injuries have been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling three Artis Q.zen floor angiography systems due to a device malfunction affecting X-ray firing.
The affected devices are Model 10848353 with serial numbers 105500, 105503, and 105501. When the source-to-image distance (SID) lift movement is activated simultaneously with an X-ray release command, the system fails to fire X-rays. Instead, an error message appears stating 'No x-ray, try again.' This timing conflict results in a short delay in the procedure.
The systems were distributed nationwide. Healthcare facilities using these specific serial numbers should be aware of this operational limitation when the SID lift and X-ray commands are activated at the same time.
The recalled product
- Product
- Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353
- 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: 105500 105503 105501
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 · x ray failure
See all →- ModerateMedical Imaging System May Fail to Release X-rays Under Specific Conditions
FDA (Devices) · 2021-12-01