Siemens AXIOM Artis MP X-ray Generator Recall for Power Supply Issue
Siemens is recalling 24 AXIOM Artis MP units because a power supply tolerance issue may cause generator failure, preventing X-ray procedures.
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, but the hazard is a functional failure (inability to perform X-rays) rather than a direct safety risk like radiation exposure or electrical shock, and no injuries are reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 24 units of the AXIOM Artis MP, Model Number 5904466, due to a tolerance issue in the power supply of the generator control. This defect may cause the generator A100 to fail, resulting in the X-ray tube not receiving the required voltage and 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. Specific serial numbers for the recalled units are listed in the official recall documentation.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- AXIOM Artis MP, Model Number 5904466
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — X-ray Equipment
- Hazard
- Affected units
- 24
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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