—#98764

Product

ACUSON S2000 ultrasound system Manufactured by Siemens Medical Solutions USA, Inc. Business Unit Ultrasound, 1230 Shorebird Way Intended for the following applications: Fetal, abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal and Peripheral Vascular Applications.

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K082142
Affected lot / code info: Model Number 10041461-ACUSON S2000. Serial numbers to follow

Why it was recalled

The Firm discovered a software error on the Accuson S2000 ultrasound systems affecting the measurement results in the patient report.

Root cause (FDA determination)

Software design

Action the firm took

Siemens issued a Customer Safety Advisory Notification letter to all customers on March 15, 2011, regarding a software error on the ACUSON S2000 ultrasound systems affected measurement . They are in the process of releasing a software update that will correct this issue. Siemens recommends reviewing the patient report at the end of each study to confirm that the report contains only measurements relevant to the exam just performed. No patient injury has been reported. Further questions regarding this recall please call (650) 694-5398.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 1230 Shorebird Way P.O. Box 7393, Mountain View, California 94043

Distribution

Distribution pattern: Worldwide Distribution including USA, states of AZ, VA, CA, NE, IL, MN, TN, FL, NM, and DC

Timeline

Recall initiated: 2011-03-15
Posted by FDA: 2011-04-22
Terminated: 2012-06-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98764. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.