Siemens ARTIS Icono Biplane and Floor Systems Recalled for Software Errors
Siemens is recalling 41 ARTIS Icono systems with software version VE20B due to misleading error messages and manual gaps that may cause procedure termination.
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 involves software errors and documentation gaps that may lead to procedure termination, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 41 units of the ARTIS Icono biplane (Model 11327600) and ARTIS Icono floor system (Model 11327700) equipped with software version VE20B. These devices are intended for single and biplane diagnostic imaging and interventional procedures. The recall affects units distributed nationwide in the United States.
The recall is due to misleading error messages and a gap in the Operator Manual. These issues affect system error management, erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. The source text notes that these issues may cause procedures to be terminated and performed on an alternative x-ray system.
No specific injuries or illnesses are reported in the source text. Affected serial numbers are listed in the agency's recall record. Users should contact Siemens Medical Solutions USA, Inc. for further instructions on resolving the software and documentation issues.
The recalled product
- Product
- ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 41
Distribution
Distributed nationwide across the United States.
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
- HighSiemens ARTIS Icono X-Ray System Recalled for Software Misalignment
FDA (Devices) · 2020-11-11
- ModerateSiemens Recalls ARTIS X-Ray Systems Due to Software Issue
FDA (Devices) · 2021-05-05
- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- HighArtis icono diagnostic imaging system software defects recalled nationwide
FDA (Devices) · 2022-02-02
- HighSiemens Artis icono X-Ray Systems Recalled for Potential Hardware Failure
FDA (Devices) · 2022-09-07
- HighMedical imaging system software errors may delay treatment procedures
FDA (Devices) · 2022-04-27