Siemens Artis zee x-ray system may delay imaging delivery during procedures
Siemens is recalling Artis zee ceiling-mounted x-ray imaging systems equipped with VD12 software. A software issue may prevent x-ray delivery when the source-to-image distance lift is activated during procedures, resulting in procedural delays.
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 no reported injuries or illnesses. The issue is a software operational defect causing procedural delays rather than a direct safety hazard with reported adverse events.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling Artis zee ceiling-mounted x-ray systems equipped with VD12 software used for diagnostic imaging and interventional procedures. The recall affects 8 units distributed nationwide.
The recalled systems have a software issue: when the source-to-image distance (SID) lift mechanism is activated while x-ray release is simultaneously attempted, the x-ray cannot be delivered. Instead, the system displays a message stating "No x-ray, try again," resulting in a short delay in the procedure.
The recalled product
- Product
- Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- operational-defect
- software-malfunction
Distribution
Distributed nationwide across the United States.
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