Siemens AXIOM Artis dBC X-ray System Recalled for Power Supply Issue
Siemens is recalling one AXIOM Artis dBC X-ray system because a power supply defect may prevent X-ray generation 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. The hazard is a functional failure preventing X-ray generation, which is a significant operational issue but does not involve direct physical injury, death, or serious health consequences as defined in the rubric for higher severity levels.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling one unit of the AXIOM Artis dBC, Model Number 5917054, X-ray system. 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 it impossible to generate X-rays.
The issue occurs sporadically but may happen during an ongoing procedure. The affected unit has Serial Number 49008 and was distributed nationwide in the United States.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this defect.
The recalled product
- Product
- AXIOM Artis dBC, Model Number 5917054
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 1
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: 49008
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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