Agency classClass IIOur severity:High FDA (Devices)·Z-0472-2022·Announced 2022-01-19

CT Scanner Software Defect May Degrade Image Quality Nationwide

Siemens SOMATOM Confidence CT scanners with software version VB20_SP5 may experience degraded head image quality, creating a potential risk of misdiagnosis. The recall affects 108 units distributed nationwide.

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: This is a Class II FDA recall of a diagnostic imaging system where the hazard is theoretical (potential image degradation leading to potential misdiagnosis) with no reported illnesses or injuries. Per the rubric, risk-of-harm products without reported injury are scored as High.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 108 SOMATOM Confidence computed tomography (CT) systems, Model 10590100, distributed nationwide. The recall affects units with the specific serial numbers listed and software version VB20_SP5.

The affected software version may lead to degradation of head image quality during CT imaging. This quality degradation creates a potential risk that patients could be misdiagnosed based on the reduced image quality.

Patients who have undergone head CT scans using these systems should discuss any imaging quality concerns with their healthcare providers. Healthcare facilities operating the affected systems should contact the manufacturer for further guidance.

The recalled product

Product: SOMATOM Confidence -Computed tomography systems Model 10590100
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic Imaging
Hazard: image-quality-degradation
misdiagnosis-risk
software-defect
Affected units: 108

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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 · image quality degradation