Siemens AXIOM Artis dMP X-ray Generator Recall for Power Supply Issue
Siemens is recalling 32 AXIOM Artis dMP units because a power supply tolerance issue 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 generate X-rays) rather than a direct physical injury or contamination risk, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 32 units of the AXIOM Artis dMP, Model Number 7555365, due to a tolerance issue in the power supply of the generator control. The affected units were distributed nationwide in the United States.
The issue may cause the generator A100 to fail if the tolerance exceeds a specific value. When this occurs, the X-ray tube is not supplied with the required voltage, making it impossible to generate X-rays. The failure is sporadic but may happen during an ongoing procedure.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the issue. The specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- AXIOM Artis dMP, Model Number 7555365
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 32
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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