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
- Hazard
- x-ray-failure
- device-malfunction
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.
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