Agency classClass IIOur severity:High FDA (Devices)·Z-0400-2021·Announced 2020-11-11

Siemens ARTIS Icono X-Ray System Recalled for Software Misalignment

Siemens is recalling ARTIS Icono X-ray systems due to a software defect that may cause inaccurate image overlays, potentially leading to patient danger.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The source text explicitly states the defect 'could imply danger to the patient' but does not report any specific injuries, hospitalizations, or deaths. This aligns with the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the ARTIS Icono Interventional Fluoroscopic X-Ray system due to a software problem in the DSA Roadmap application. The issue affects systems running software version VE20B. In rare cases, if the DSA acquisition starts while the C-Arm or table is moving, the resulting vessel map may be misaligned with the subtracted fluoroscopic image.

This misalignment could cause the user to rely on an incorrect visualization of the catheter relative to the vessel map, which the source text states could imply danger to the patient. The recall covers 100 units distributed worldwide, with 31 units distributed nationwide in the U.S.

Affected units include the ARTIS Icono biplane (model # 11327600) and ARTIS Icono Floor (model # 11327700). Specific 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 issue.

The recalled product

Product: ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging Equipment
Hazard: software-defect
patient-danger

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →

Moderate
ARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
High
ARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
Moderate
ARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
High
ARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
High
ARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10

Same hazard · software defect