Siemens Artis One X-Ray System Recalled for Data Mirroring Error
Siemens is recalling one Artis One angiography system because imported left atrium segmentation results may be incorrectly mirrored to a 3D mapping system.
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 source text does not report any hospitalizations, injuries, or illnesses. The hazard is a data integrity issue (mirroring) rather than a direct physical injury risk, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling one Artis One Interventional Fluoroscopic x-ray system. The recall is due to a software issue where imported segmentation results of the left atrium may be mirrored when transferred to an electro-anatomical 3D mapping system, specifically the CARTO system from Biosense Webster Inc.
The affected unit is identified by Serial # 82010 and material # 10848600. The distribution pattern is listed as nationwide distribution to Michigan only. The source text does not report any injuries, illnesses, or deaths associated with this defect.
Hospitals and facilities using the affected system should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the data mirroring issue.
The recalled product
- Product
- Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Imaging System
- 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 (2)
- Serial # 82010
- material # 10848600
Distribution
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 · software error
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- ModerateBeckman Coulter AU480 Chemistry Analyzer Software Error Recall
FDA (Devices) · 2026-10-07
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateSiemens Artis One Angiography System Recalled for Monitor Failure
FDA (Devices) · 2015-02-25
- ModerateSiemens Artis one X-ray Systems Recalled for Monitor Display Issues
FDA (Devices) · 2018-02-21
- HighSiemens Artis one Fluoroscopic X-Ray System Recalled for Table Defect
FDA (Devices) · 2018-03-28
- ModerateSiemens Artis one Fluoroscopic X-Ray Systems Recalled for Monitor Malfunction
FDA (Devices) · 2020-11-04
- HighSiemens ARTIS Icono X-Ray System Recalled for Software Misalignment
FDA (Devices) · 2020-11-11
- HighSiemens Artis zee/zeego Angiographic X-ray Systems Recalled for Footswitch Defect
FDA (Devices) · 2016-11-23