Siemens Artis Q Biplane X-ray System Software Imaging Delay Issue
Siemens Medical Solutions is recalling 15 Artis Q biplane diagnostic x-ray systems due to a software issue in the VD12-angiography subsystem. When source-to-image distance lift is activated simultaneously with x-ray release, the system fails to activate and displays an error message, causing 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 classification indicates moderate concern. No injuries or illnesses have been reported. The source explicitly describes the consequence as a procedural delay rather than a direct safety or health risk, which places this at Moderate severity per the rubric for low-risk operational issues without reported injury potential.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 15 Artis Q biplane diagnostic imaging systems (Model 10848282) distributed nationwide in the United States. These systems are used for single and biplane diagnostic imaging and interventional procedures.
The recalled systems have a software issue affecting the VD12-angiography subsystem. When source-to-image distance (SID) lift movement is activated simultaneously with x-ray release, the x-ray does not activate. Instead, the system displays the message "No x-ray, try again," which may result in a short delay in the procedure.
The recall affects 15 units with the following serial numbers: 122025, 122012, 122022, 122021, 122005, 121209, 122017, 122001, 134500, 122010, 122007, 122016, 122013, 122024, and 122014.
Healthcare facilities using affected units should contact Siemens Medical Solutions for instructions. The FDA classified this as a Class II recall.
The recalled product
- Product
- Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- equipment-malfunction
- imaging-delay
Distribution
Distributed nationwide across the United States.
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