Siemens Medical Solutions USA, Inc. Siemens ACUSON X300 Systems with software versions 3.0.00 and 3.0.02, model numbers 10348531, 10348532 and 10348533, manufactured by Siemens Medical Solutions, Mountain View, CA. Intended for General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Siemens ACUSON X300 Systems with software versions 3.0.00 and 3.0.02, model numbers 10348531, 10348532 and 10348533, manufactured by Siemens Medical Solutions, Mountain View, CA. Intended for General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
Systems with software versions 3.0.00 and 3.0.02.
Products Sold
Systems with software versions 3.0.00 and 3.0.02.
Siemens Medical Solutions USA, Inc. is recalling Siemens ACUSON X300 Systems with software versions 3.0.00 and 3.0.02, model numbers 10348531, 103485 due to Mistreatment risk-- when a user defined formula is used to calculate a value in a vascular exam, data is switched laterally when it is internally tran. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mistreatment risk-- when a user defined formula is used to calculate a value in a vascular exam, data is switched laterally when it is internally transferred and displayed on the summary report within the system.
Recommended Action
Per FDA guidance
A field correction was initiated and a Customer Safety Advisory Notification was sent out on 7/29/09. The letter identified the affected product and stated that there was a potential for user defined calculations to be incorrect within the vascular package when using the listed software versions of the product. The letter also discussed the steps that customers could take to avoid the potential risk of the issue. A mandatory update software was developed and will be installed free of charge. Customers should have been contacted to schedule a time for the installation. Questions were to be directed to the local service support person.
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