Siemens Medical Solutions USA, Inc. Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model numbers 10037409, 10132987, and 10038837, manufactured by Siemens Medical Solutions ultrasound business unit, Mountain View, CA Medical device is an ultrasound imaging system for general radiology, fetal, abdominal, intraoperative, pediatric, small parts, neonatal/adult cephalic, cardiac, transesophageal, pelvic, transcranial, ob/gyn, urology, vascular, musculoskeletal, superficial musculoskeletal and periphe Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model numbers 10037409, 10132987, and 10038837, manufactured by Siemens Medical Solutions ultrasound business unit, Mountain View, CA Medical device is an ultrasound imaging system for general radiology, fetal, abdominal, intraoperative, pediatric, small parts, neonatal/adult cephalic, cardiac, transesophageal, pelvic, transcranial, ob/gyn, urology, vascular, musculoskeletal, superficial musculoskeletal and periphe
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
Serial numbers
Products Sold
Serial numbers
Siemens Medical Solutions USA, Inc. is recalling Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model numbers 10037 due to Software Error with potential for misinterpretation of data-- The previous patient's last capture clip image can appear in the next patient's study.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software Error with potential for misinterpretation of data-- The previous patient's last capture clip image can appear in the next patient's study.
Recommended Action
Per FDA guidance
The firm, Siemens, sent a "CUSTOMER SAFETY ADVISORY NOTIFICATION" letter to its customers on July 30, 2009. The letter described the product, problem and actions to be taken. The customers were instructed they need to update any of the patient registration settings to reset the cine buffer so that no data is transferred between studies, if the system software is not being updated. Siemens informed the customers that a mandatory update software is being installed on their system free of charge. If you have any questions, contact (650) 969-9112.
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