Siemens ARTIS Pheno X-Ray Systems Recalled for Drivetrain Faults
Siemens is recalling 105 ARTIS Pheno X-ray systems because a drivetrain fault may prevent the C-arm from moving, requiring field service to restore operation.
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, and the hazard involves a functional defect that prevents the device from operating as intended, requiring field service to resolve. No injuries or illnesses are reported, and the risk is primarily operational rather than direct physical harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 105 units of the ARTIS Pheno Interventional Fluoroscopic X-Ray System (Model 10849000). These systems are used for diagnostic imaging and interventional procedures, including those for pediatric and obese patients. The recall covers units distributed nationwide in the United States.
The recall is due to a potential fault within the drivetrain that may cause the C-arm to leave its intended travel path. If this occurs, the C-arm's movements may be impacted or impossible, preventing the system from reaching the area of interest. In such cases, the system can only be returned to normal operation with the support of a field service engineer.
Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice. Siemens is providing support to resolve the issue, and facilities should contact the manufacturer for instructions on how to proceed with the recall.
The recalled product
- Product
- ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is a family of dedicated angiography systems 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
- Affected units
- 105
Distribution
Distributed nationwide across the United States.
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