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.
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 3/5 (High).
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
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