Siemens AXIOM Artis dFC X-ray Generator Recall for Power Supply Issue
Siemens is recalling 148 AXIOM Artis dFC units because a power supply defect may cause the X-ray generator to fail during procedures.
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 hazard is a functional failure (inability to produce X-rays) rather than a direct physical injury or contamination, and no injuries are reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 148 units of the AXIOM Artis dFC, Model Number 7412807, due to a tolerance issue in the power supply of the generator control. The affected units were distributed nationwide in the United States.
The defect may cause the generator A100 to fail if the power supply exceeds a specific value. When this failure occurs, the X-ray tube is not supplied with the required voltage, making it impossible to produce X-rays. The issue is sporadic but may occur during an ongoing procedure.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with this recall.
The recalled product
- Product
- AXIOM Artis dFC, Model Number 7412807
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — X-ray Equipment
- Hazard
- Affected units
- 148
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 23 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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