Siemens Artis Q.zen Angiography System X-ray Activation Failure
Siemens is recalling 15 Artis Q.zen angiography systems that may fail to generate x-rays when the lift mechanism and x-ray release are activated simultaneously, potentially causing 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: The source describes an operational issue with no reported injuries or illnesses. While FDA Class II, the issue results in a procedural delay rather than a patient safety hazard, with no harm reported. This fits the Moderate category for functional issues without reported injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 15 units of the Artis Q.zen ceiling-mounted angiography system (Model 10848354). This imaging equipment is used for diagnostic imaging and interventional procedures.
The recall is due to a functional issue that occurs when the source-to-image distance (SID) lift mechanism and x-ray release are activated simultaneously. Under these conditions, the system fails to generate x-rays and instead displays a 'No x-ray, try again' message. This may result in a short delay during procedures.
The affected units, identified by their serial numbers, were distributed nationwide in the United States.
The recalled product
- Product
- Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 15
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.
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