Siemens Artis One Angiography System Recalled for Monitor Failure
Siemens Medical Solutions is recalling one Artis One angiography system because the monitor may fail and require a power cycle to resume operation.
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 describes a sporadic, non-systematic monitor failure that requires a power cycle to fix, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling one unit of the Artis One angiography system. The system is used for diagnostic interventional procedures, including cardiac, neuro, and general angiography, as well as whole-body radiographic and fluoroscopic procedures.
The recall is due to a sporadic issue where the monitor may fail and requires a power cycle (shutdown and then power on) to resume operation. The problem is not systematic and affects single units. The specific unit involved is Model Number 10848600, serial number 82010.
The distribution pattern is listed as nationwide distribution to Michigan only. No injuries or illnesses have been reported in the source text.
The recalled product
- Product
- Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general…
- 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 (2)
- Model Number 10848600
- serial number 82010
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 · monitor failure
See all →- SeverePhysio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Lockup Condition
FDA (Devices) · 2019-03-06
- HighGE Healthcare Optima IGS 320 Recall for Loss of Displayed Imaging
FDA (Devices) · 2015-12-23
- HighGE Healthcare Recalls Optima CL323i and IGS 320 X-ray Systems
FDA (Devices) · 2015-12-23
Similar recalls
- ModerateSiemens Artis one X-ray Systems Recalled for Monitor Display Issues
FDA (Devices) · 2018-02-21
- ModerateSiemens Artis One X-Ray System Recalled for Data Mirroring Error
FDA (Devices) · 2016-04-06
- HighSiemens Recalls Artis Q Angiographic X-Ray Systems for Generator Defects
FDA (Devices) · 2017-01-18
- HighSiemens Artis one Fluoroscopic X-Ray System Recalled for Table Defect
FDA (Devices) · 2018-03-28
- HighSiemens Artis Q. Angiography System Recalled for Potential Hardware Thermal Issue
FDA (Devices) · 2018-08-22
- ModerateSiemens Artis one Fluoroscopic X-Ray Systems Recalled for Monitor Malfunction
FDA (Devices) · 2020-11-04