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.
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 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.
See all 23 products in this recall →Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · functional failure
See all →- ModerateOlympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
- HighAccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
FDA (Devices) · 2026-04-29
- HighBaxter TruSystem 7500 Hybrid software issue disables upper back adjustment
FDA (Devices) · 2025-04-02
- HighSoftware Malfunction Disables Back Control on Baxter TruSystem 7500
FDA (Devices) · 2025-04-02
- SevereCardiac catheters recalled due to polyurethane layer delamination defects
FDA (Devices) · 2024-05-22
Similar recalls
- HighSiemens AXIOM Artis zee/zeego Systems Recalled for Generator Power Supply Defect
FDA (Devices) · 2013-07-24
- ModerateX-ray imaging system hardware defect may prevent operation
FDA (Devices) · 2022-09-07
- HighSiemens Axiom Artis Medical Devices Recalled for Liquid Entry Risk
FDA (Devices) · 2018-03-07
- HighSiemens Artis X-Ray Systems Recalled for Electrical Contact Issues
FDA (Devices) · 2020-06-17
- HighSiemens Recalls Artis Q Angiographic X-Ray Systems for Generator Defects
FDA (Devices) · 2017-01-18
- HighSiemens AXIOM Artis angiographic x-ray systems recalled for coolant leaks
FDA (Devices) · 2018-03-28