Siemens ACUSON SC2000 Ultrasound Systems Recalled for Hardware Defects
Siemens is recalling 2,099 ACUSON SC2000 ultrasound systems due to hardware defects involving wheel lock disconnection and system lockups.
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 2/5 (Moderate).
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 hazards involve mechanical disconnection and software lockups, which are operational defects without reported injuries or deaths, fitting the criteria for moderate severity.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 2,099 ACUSON SC2000 ultrasound systems, model 10433816. These imaging systems are used to measure anatomical structures and provide information for clinical diagnosis.
The recall addresses two specific hardware issues: the metal component used to engage the wheel lock may become disconnected, and the system may lock up due to misalignment between the bezel and the MPI board. The affected units were distributed worldwide, including in the United States and numerous international locations.
Siemens will provide customers with a new version of system software (VA35E or VB10C, depending on hardware configuration) and implement hardware fixes to resolve these issues in all units that have not already been corrected.
The recalled product
- Product
- ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 2,099
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- and 402441.
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc.
See all →- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateSiemens ACUSON SC2000 Ultrasound System Recalled for Control Panel Lock Failure
FDA (Devices) · 2014-02-05
- ModerateSiemens ACUSON SC2000 Ultrasound System Control Panel Bolt Recall
FDA (Devices) · 2015-02-11
- ModerateSiemens ACUSON SC2000 Ultrasound System Recalled for Data Capture Error
FDA (Devices) · 2015-09-23
- ModerateSiemens ACUSON SC2000 Ultrasound Systems Recalled for Software Display Errors
FDA (Devices) · 2014-06-04
- ModerateSiemens ACUSON SC2000 Ultrasound Systems Recalled for Image Capture Failures
FDA (Devices) · 2015-05-13
- SevereSiemens Acuson SC2000 Ultrasound Systems Recalled for Inaccurate 3D Images
FDA (Devices) · 2013-10-30