Siemens Medical Solutions USA, Inc. Siemens brand ACUSON S2000 Ultrasound System with software versions: VA10, VA10A, VA10B, VA10C, VA15; Model Number: 10041461; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc. Ultrasound Business Unit, Mountain View, CA The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, a Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Siemens brand ACUSON S2000 Ultrasound System with software versions: VA10, VA10A, VA10B, VA10C, VA15; Model Number: 10041461; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc. Ultrasound Business Unit, Mountain View, CA The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, a
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
All units of this model.
Products Sold
All units of this model.
Siemens Medical Solutions USA, Inc. is recalling Siemens brand ACUSON S2000 Ultrasound System with software versions: VA10, VA10A, VA10B, VA10C, VA15 due to The product has a software problem in which previous patient measurement data gets associated with another patient's image.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product has a software problem in which previous patient measurement data gets associated with another patient's image.
Recommended Action
Per FDA guidance
The firm, SIEMENS, issued a "CUSTOMER SAFETY ADVISORY NOTIFICATION" letter to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that the first image in Exam Review is from the current patient; ensure that the Heart Cycle measurement tool is not selected on the Cale menu when entering Exam Review; be aware of this issue as described in the letter and perform four (4) or less measurements of the same measurement label. Should you have any questions, please call (650) 694-5398.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026