Siemens AXIOM Artis BA X-ray Systems Recalled for Power Supply Defect
Siemens is recalling seven AXIOM Artis BA X-ray systems because a power supply defect may cause the generator to fail, preventing 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 generate X-rays) rather than a direct physical injury or contamination, fitting the 'Moderate' criteria for low-risk issues or voluntary precautionary actions without reported harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling seven units of the AXIOM Artis BA, Model Number 5904656, X-ray systems. The recall is due to a tolerance issue in the power supply of the generator control that may cause the generator A100 to fail. This failure prevents the X-ray tube from receiving the required voltage, 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. The specific serial numbers for the recalled units are 28159, 28144, 28154, 28139, 28155, 28160, and 28156.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this defect. The recall is classified as Class II by the FDA, indicating that the defect could cause temporary or medically reversible health consequences.
The recalled product
- Product
- AXIOM Artis BA, Model Number 5904656
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — X-ray Systems
- Hazard
- Affected units
- 7
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: 28159 28144 28154 28139 28155 28160 28156
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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