Siemens ACUSON Sequoia Ultrasound Systems Recalled for Incorrect Delivery Date Calculations
Siemens is recalling 1,172 ACUSON Sequoia ultrasound systems because a software error may calculate incorrect Estimated Dates of Delivery, potentially influencing clinical decisions.
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 where injury (premature birth) has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,172 ACUSON Sequoia Diagnostic Ultrasound Systems. The recall is due to a software issue where the system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This error may result in an incorrect EDD.
The affected systems are distributed across the United States and numerous international locations. The incorrect EDD calculation may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births.
Healthcare providers should contact Siemens Medical Solutions USA, Inc. for instructions on how to correct the software error. Consumers and patients should consult their healthcare providers regarding any ultrasound results obtained from these systems.
The recalled product
- Product
- Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 1,172
Distribution
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 · incorrect calculation
See all →- HighClinical Chemistry Analyzer Recalled for Software Defect in Test Result Calculation
FDA (Devices) · 2025-04-09
- ModerateRoche uPath software 1.1 recalled for incorrect measurement calculations
FDA (Devices) · 2021-01-27
- HighIntellijoint Navigation System Software Recalled for Incorrect Knee Surgery Calculations
FDA (Devices) · 2020-04-01
- SevereElekta Monaco RTP System Recalled for Incorrect Wedge Calculations
FDA (Devices) · 2017-01-18
- HighPhilips EPIQ 5 Ultrasound System Recalled for Body Surface Area Calculation Error
FDA (Devices) · 2015-05-27