Siemens AXIOM Artis dBC X-ray Generator Recall for Power Supply Defect
Siemens is recalling 53 AXIOM Artis dBC units due to a power supply tolerance issue that can cause generator failure and prevent X-ray imaging.
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 failure (inability to perform X-ray) rather than a direct physical injury or death, fitting the criteria for moderate severity.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 53 units of the AXIOM Artis dBC, Model Number 7728392, due to a tolerance issue in the power supply of the generator control. This defect may cause the generator A100 to fail, resulting in the X-ray tube not receiving the required voltage and making X-ray imaging impossible.
The issue occurs sporadically but may happen during an ongoing procedure. The affected units were distributed nationwide in the United States. Specific serial numbers for the affected units are listed in the official recall documentation.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. 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
- AXIOM Artis dBC, Model Number 7728392
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 53
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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