Siemens ACUSON SC2000 Ultrasound System Recalled for Data Capture Error
Siemens is recalling ACUSON SC2000 ultrasound systems because a software error prevents the capture of images or clips when patient names are registered with different capitalization.
What this means for you
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 is a software defect leading to data loss (failure to capture images), which is a significant functional issue but does not involve direct physical injury, death, or high-risk biological pathogens, fitting the Moderate category for non-injurious functional defects.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 2,039 ACUSON SC2000 ultrasound systems, Model 10433816, equipped with software versions VB10B and lower. The recall is due to a software defect where the system treats uppercase and lowercase differences in the same patient name as unique patient instances.
If these capitalization differences are not corrected at the time of registration, the system fails to capture images or clips. This issue affects the system's ability to store data for clinical diagnosis purposes.
The affected devices were distributed worldwide, including the United States and numerous international markets. Siemens is the recalling firm. No specific consumer action is detailed in the provided source text beyond the identification of the defect.
The recalled product
- Product
- ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 2,039
Distribution
Distributed nationwide across the United States.
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