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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 Device Recall Acuson/Sonovista X300 see related information
Date Initiated by Firm August 19, 2008
Date Posted October 08, 2008
Recall Status1 Terminated 3 on April 21, 2011
Recall Number Z-0086-2009
Recall Event ID 49411
510(K)Number K061946  
Product Classification diagnostic ultrasound - 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 CA 94039-7393
For Additional Information Contact
650-694-5993
Manufacturer Reason
for Recall		 Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates.
FDA Determined
Cause 2		 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 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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