Siemens Artis Q floor angiography system: X-ray failure during SID lift operation
Siemens Artis Q floor angiography systems may fail to produce x-ray when SID lift movement is activated during x-ray release, resulting in procedural delays. The system displays an error message.
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: This is a FDA Class II recall with no reported injuries or illnesses. The documented issue is an operational/functional failure causing procedural delays, not a safety hazard with potential to cause patient harm. Per the rubric, Class II recalls without reported injuries typically score as Moderate.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling Artis Q floor with software VD12 angiography systems used for single and biplane diagnostic imaging and interventional procedures. Eight units are affected, identified by specific serial numbers.
The systems have a functional issue where x-ray imaging may not operate properly when the SID (source-to-image distance) lift movement is activated while x-ray release occurs simultaneously. When this condition occurs, the x-ray does not function and the system displays an error message stating 'No x-ray, try again.' This results in a short delay in procedures using affected systems.
Healthcare facilities with affected units should contact Siemens Medical Solutions for further guidance. Users of these systems should be aware of this operational limitation when both SID lift movement and x-ray release are activated at the same time.
The recalled product
- Product
- Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- device-malfunction
- imaging-failure
Distribution
Distributed nationwide across the United States.
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