Siemens ARTIS Q Biplane Recalled for C-Arm Vibration Issues
Siemens is recalling 54 ARTIS Q biplane x-ray systems because C-arm vibrations may reduce image quality due to a ceiling support screw connection.
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: The recall is classified as FDA Class II, but the source text explicitly states the issue results in reduced image quality without reporting any injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 54 units of the ARTIS Q biplane angiographic x-ray system. 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 distributed nationwide in the United States. The recall covers specific serial numbers listed in the agency's official documentation. The product is a dedicated angiography system used for diagnostic imaging and interventional procedures, including those for pediatric and obese patients.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the issue. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- Product
- ARTIS Q biplane with Material 10848282- - 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
- 54
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.
See all 3 products in this recall →Related recalls
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Same hazard · reduced image quality
See all →- ModerateSiemens Artis zee Biplane Systems Recalled for C-Arm Vibration Issues
FDA (Devices) · 2018-11-21
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Similar recalls
- SevereSiemens Artis Biplane Systems Recalled for Ceiling Mount Defect
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- HighSiemens Artis Q Angiography Systems Recalled for Software Movement Issue
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- ModerateSiemens Artis Q.zen Angiography Systems Recalled for Software Movement Issue
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- SevereSiemens Artis X-Ray Systems Recalled for Potential Ceiling Mount Failure
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- HighSiemens Recalls Artis Q Angiographic X-Ray Systems for Generator Defects
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- SevereSiemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure
FDA (Devices) · 2019-07-10