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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 January 14, 2009
Date Posted April 06, 2011
Recall Status1 Terminated 3 on April 06, 2011
Recall Number Z-1900-2011
Recall Event ID 51497
510(K)Number K082142  
Product Classification Counter, differential cell - Product Code GKZ
Product Siemens brand ACUSON S2000 Ultrasound System with software versions:
VA10, VA10A, VA10B, VA10C, VA15; Model Number: 10041461;
Product is manufactured and distributed by Siemens Medical Solutions USA, Inc. Ultrasound Business Unit, Mountain View, CA

The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.
Code Information All units of this model.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View CA 94043
For Additional Information Contact
650-694-5993
Manufacturer Reason
for Recall		 The product has a software problem in which previous patient measurement data gets associated with another patient's image.
FDA Determined
Cause 2		 Software change control
Action The firm, SIEMENS, issued a "CUSTOMER SAFETY ADVISORY NOTIFICATION" letter to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that the first image in Exam Review is from the current patient; ensure that the Heart Cycle measurement tool is not selected on the Cale menu when entering Exam Review; be aware of this issue as described in the letter and perform four (4) or less measurements of the same measurement label. Should you have any questions, please call (650) 694-5398.
Distribution Worldwide distribution.
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 = GKZ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
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