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.
This recall has been terminated (originally issued April 22, 2011).
- Recall Initiated
- March 15, 2011
- Posted
- April 22, 2011
- Terminated
- June 18, 2012
- Recall Number
- Z-2051-2011
- Quantity
- 1533 units
- Firm Location
- Mountain View, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The Firm discovered a software error on the Accuson S2000 ultrasound systems affecting the measurement results in the patient report.
Distribution
Worldwide Distribution including USA, states of AZ, VA, CA, NE, IL, MN, TN, FL, NM, and DC
Lot / Code Info
Model Number 10041461-ACUSON S2000. Serial numbers to follow
Root Cause
Software design
Action Taken
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.