Siemens ACUSON SC2000 Ultrasound System Recalled for Loose User Interface
Siemens Medical Solutions is recalling 843 ACUSON SC2000 ultrasound systems because the user interface assembly may become loose and fall off.
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 risk-of-harm product (medical device) where a component may fall off, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 843 active units of the ACUSON SC2000 Ultrasound System. The recall is due to a defect where the user interface assembly may become loose, creating a potential for the entire module to fall off of the ultrasound system.
The affected systems are distributed worldwide, including in the United States and numerous other countries. The specific units involved are identified by Model number 10433816 and serial numbers lower than 401100. A comprehensive list of affected serial numbers is available in the official recall documentation.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this issue. The company is the recalling firm and is responsible for managing the corrective actions for these devices.
The recalled product
- Product
- ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pedi
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 843
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)
- Model number 10433816
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 · falling object
See all →- HighFord F-650 SD Recall: Liftgate Platform Deck Pins May Break
NHTSA · 2026-08-20
- SevereTerex Digger Derrick Trucks Recalled for Weld Defect
NHTSA · 2026-08-17
- SevereIsuzu NPR HD Liftgate Deck Pin Recall
NHTSA · 2026-08-06
- HighWabash Recalls 2025-2026 Dry Truck Bodies Due to Liftgate Pin Failure
NHTSA · 2026-07-14
- HighMarion Body Works Recalls Waltco Liftgates on Morgan Dry Vans
NHTSA · 2026-06-12