Siemens SOMATOM Edge Plus CT Systems Recalled for Software Issues
Siemens is recalling SOMATOM Edge Plus CT systems due to four safety-related software issues in syngo.CT version VB10A that may cause scan aborts.
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: The recall involves a medical device with a potential for safety-related issues that may result in a scan abort, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling SOMATOM Edge Plus computed tomography (CT) systems, Model Number 10267000. The recall involves specific serial numbers listed in the agency record. These systems are intended to generate and process cross-sectional images of patients for diagnostic and treatment planning purposes.
The recall is due to four potential safety-related software issues affecting systems utilizing syngo.CT software version VB10A. These issues may result in a scan abort. The source text does not specify the exact nature of the software defects or the specific patient safety consequences beyond the interruption of the scan.
The affected units were distributed nationwide in the United States. The source text does not provide instructions for consumers or healthcare facilities on how to address the recall, nor does it report any injuries or illnesses associated with the defect.
The recalled product
- Product
- SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician a
- Manufacturer
- Siemens Medical Solutions USA, Inc
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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 7 products in this recall →Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25