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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 Recall
Sonoline G50/G60 Ultrasound System
see related information
Date Posted September 29, 2008
Recall Status1 Open
Recall Number Z-2468-2008
Recall Event ID 49377
Premarket Notification
510(K) Number
K052894 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - 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, California 94043
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
DESIGN: 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 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.
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