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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 system see related information
Date Initiated by Firm March 15, 2011
Date Posted April 22, 2011
Recall Status1 Terminated 3 on June 18, 2012
Recall Number Z-2051-2011
Recall Event ID 58231
510(K)Number K082142  
Product Classification Ultrasonic Pulsed Doppler Imaging System - 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 CA 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		 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 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) Database 510(K)s with Product Code = IYN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
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