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U.S. Department of Health and Human Services

Class 2 Device Recall Acuson S2000 ultrasound system

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 Class 2 Recall
Acuson S2000 ultrasound system
see related information
Date Posted April 22, 2011
Recall Status1 Terminated on June 18, 2012
Recall Number Z-2051-2011
Recall Event ID 58231
Premarket Notification
510(K) Number
K082142 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
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.
Code Information Model Number 10041461-ACUSON S2000. Serial numbers to follow
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94043
For Additional Information Contact Sheila Pickering
650-694-5398
Manufacturer Reason
for Recall
The Firm discovered a software error on the Accuson S2000 ultrasound systems affecting the measurement results in the patient report.
FDA Determined
Cause 2
DESIGN: Software Design
Action 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.
Quantity in Commerce 1533 units
Distribution Worldwide Distribution including USA, states of AZ, VA, CA, NE, IL, MN, TN, FL, NM, and DC
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
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