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.
FDA Recall Z-0086-2009 · Posted 2008-10-08
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Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2008-08-19
Date Terminated2011-04-21
Product Quantity169 units total
Reason for Recall
Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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