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U.S. Department of Health and Human Services

Class 2 Device Recall Acuson/Sonovista X300

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 Class 2 Recall
Acuson/Sonovista X300
see related information
Date Posted October 08, 2008
Recall Status1 Open
Recall Number Z-0086-2009
Recall Event ID 49411
Premarket Notification
510(K) Number
K061946 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions Sonovista X300 software revision 1.0.06 and 1.0.07, Acuson X300 sofware revision 1.0.08 ultrasound system with onscreen display.
Code Information Sonovista: 10133170 (Japan only) Acuson: 10037409 (potentially affected but no volume: 10132987, 10038837). Software revisions 1.0.06 and 1.0.07 for Sonovista X300 and 1.0.08 for Acuson X300
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94039-7393
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates.
FDA Determined
Cause 2
DESIGN: Software Design
Action Siemens initiated a Field Correction 08/19/2008. Service personnel will conduct a site visit and distribute a Customer Safety Advisory Notice, correct the problem and install a revised software version.
Quantity in Commerce 169 units total
Distribution Worldwide Distribution: USA, Singapore, Germany, Denmark, Romania, Sweden, Poland, Portugal, Australia, Chile, India, Spain, Thailand, Malaysia, South Africa, Hungary, Saudi Arabia, Qatar, Peru, Italy, Azerbaijan, Greenland, Austria, Venezuela, Puerto Rico, Brazil and Japan.
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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