Siemens AXIOM Artis FC X-ray Generator Recall for Power Supply Defect
Siemens is recalling five AXIOM Artis FC units due to a power supply tolerance issue that may 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, but the hazard is a functional failure (inability to produce X-rays) rather than a direct risk of physical injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling five units of the AXIOM Artis FC, Model Number 5904433, due to a tolerance issue in the power supply of the generator control. The affected units have serial numbers 10436, 10444, 10425, 10433, and 10435. These devices were distributed nationwide in the United States.
The defect 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 X-ray imaging impossible. The issue occurs sporadically and may happen during an ongoing procedure.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and repair of the affected devices.
The recalled product
- Product
- AXIOM Artis FC, Model Number 5904433
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — X-ray Equipment
- Hazard
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: 10436 10444 10425 10433 10435
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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