Siemens AXIOM Artis FA X-ray Generator Recall for Power Supply Issue
Siemens is recalling four AXIOM Artis FA units due to a power supply tolerance issue that may cause generator failure and prevent X-ray imaging.
What this means for you
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. The hazard is a functional failure preventing X-ray imaging rather than a direct physical injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling four units of the AXIOM Artis FA, Model Number 5904441. The affected units were distributed nationwide in the United States. The specific serial numbers for the recalled units are 25328, 25349, 25382, and 25403.
The recall is due to a tolerance issue in the power supply of the generator control. This issue may cause the generator A100 to fail if the tolerance exceeds a specific value. If the generator fails, the X-ray tube will not receive the required voltage, making it impossible to perform X-ray imaging. The problem occurs sporadically but may happen during an ongoing procedure.
Hospitals and medical facilities should identify if they possess any of the affected serial numbers. Siemens is the recalling firm and is responsible for addressing the defect. No specific instructions for end-users are provided in the source text, but facilities should contact Siemens for further guidance on the recall.
The recalled product
- Product
- AXIOM Artis FA, Model Number 5904441
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — X-ray Equipment
- Hazard
- Affected units
- 4
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: 25328 25349 25382 25403
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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