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.
What this means for you
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
- Hazard
- image-quality-degradation
- misdiagnosis-risk
- software-defect
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03