Siemens Artis Q.zen Biplane X-Ray System Recalled for C-Arm Vibration
Siemens Medical Solutions is recalling 15 Artis Q.zen biplane angiographic x-ray systems because C-arm vibrations may reduce image quality.
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 recall is classified as FDA Class II, but the hazard is reduced image quality rather than direct physical injury or death, fitting the Moderate category for low-risk technical defects.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 15 units of the ARTIS Q.zen biplane angiographic x-ray system (Material 10848355). The recall is due to vibrations in the C-arm of plane B, which may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support.
The affected devices are dedicated angiography systems used for diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography. The recall covers units distributed nationwide in the United States. Specific serial numbers for the affected units are listed in the official recall documentation.
Hospitals and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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