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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 8
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
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