| Class 2 Device Recall Acuson/Sonovista X300 | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = IYN
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