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U.S. Department of Health and Human Services

Class 2 Device Recall Sonoline G50/G60 Ultrasound System

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  Class 2 Device Recall Sonoline G50/G60 Ultrasound System see related information
Date Initiated by Firm August 05, 2008
Date Posted September 29, 2008
Recall Status1 Terminated 3 on December 21, 2010
Recall Number Z-2468-2008
Recall Event ID 49377
510(K)Number K052894  
Product Classification Ultrasound System - Product Code IYN
Product Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile software controlled diagnostic ultrasound system.
Code Information Model numbers 07482800, 07482818, 07482826, 07478139, 07478147, and 07482479
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
1230 Shorebire Way
P.O. Box 7393
Mountain View CA 94043
For Additional Information Contact
650-694-5993
Manufacturer Reason
for Recall		 As a result of bugs and calculation errors, the system may display incorrect or fail to display mechanical Index and thermal index values.
FDA Determined
Cause 2		 Software design
Action The firm initiated its field correction on 08/05/2008. The firm's service personnel will make site visits to correct the problem and install the revised software (version 1.5.0c). Contact Siemens Medical Solutions USA, Inc. at 1-650-694-5993 for assistance.
Quantity in Commerce 2541 units
Distribution Worldwide
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.
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