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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 Device Recall Acuson S2000 ultrasound systemsee related information
Date Initiated by FirmMarch 15, 2011
Date PostedApril 22, 2011
Recall Status1 Terminated 3 on June 18, 2012
Recall NumberZ-2051-2011
Recall Event ID 58231
510(K)NumberK082142 
Product Classification Ultrasonic Pulsed Doppler Imaging System - Product Code IYN
ProductACUSON 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
FEI Number 2936884
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View CA 94043
For Additional Information ContactSheila 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		Software design
ActionSiemens 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 Commerce1533 units
DistributionWorldwide Distribution including USA, states of AZ, VA, CA, NE, IL, MN, TN, FL, NM, and DC
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IYN
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