David M. Smith
11-13-2008, 10:27 AM
Date Recall Initiated September 18, 2007
Date Posted February 15, 2008
Recall Number Z-0719-2008
Product Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887, Siemans, Mountain View, CA 94039
Code Information Serial Numbers: 32118 30032 .....31241 Material Number 8247888-- with Serial Numbers: 31116 32673 32783 33143 31359 31775 32848 32968 Material Number 8253683: with Serial Numbers: 40290 40311 (For a complete list go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=65394)
Reason For Recall Software error: Error affects all Aspen customer systems using the PAL video standard configuration and have a Perspective PC installed. This can lead to a measurement error under this specific condition: On secondary capture images/clips stored from within any Perspective advanced display option (specifically: 3D Surface Rendering, 3D MultiPlanar Reconstruction, Color Doppler 3D MultiPlanar Reco
Action Siemens issued an Urgent Medical Device Notification to consignees 9/18/07, under Siemens update program US014/07/S. (Distribution on this product had ceased on 6/29/2005.) The firm has instructed the user to not take measurements or use measurements on these secondary captures under the conditions described in the notice, to place a copy of the instructions for use in the file, and to notify all users of the issue with the software. The Siemens Service organization has coordinated the implementation of the field correction with the distributors for all countries. Non-responding consignees will be visited or called by telephone for follow up.
Quantity in Commerce 280 units
Distribution Worldwide Distribution --- including USA and countries of Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain (UK), Greece, Hong Kong, India, Italy, Jordan, Malaysia, Norway, Poland, Portugal, Romania, Russian Federation, Sweden, Switzerland, Thailand, and Turkey.
Date Posted February 15, 2008
Recall Number Z-0719-2008
Product Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887, Siemans, Mountain View, CA 94039
Code Information Serial Numbers: 32118 30032 .....31241 Material Number 8247888-- with Serial Numbers: 31116 32673 32783 33143 31359 31775 32848 32968 Material Number 8253683: with Serial Numbers: 40290 40311 (For a complete list go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=65394)
Reason For Recall Software error: Error affects all Aspen customer systems using the PAL video standard configuration and have a Perspective PC installed. This can lead to a measurement error under this specific condition: On secondary capture images/clips stored from within any Perspective advanced display option (specifically: 3D Surface Rendering, 3D MultiPlanar Reconstruction, Color Doppler 3D MultiPlanar Reco
Action Siemens issued an Urgent Medical Device Notification to consignees 9/18/07, under Siemens update program US014/07/S. (Distribution on this product had ceased on 6/29/2005.) The firm has instructed the user to not take measurements or use measurements on these secondary captures under the conditions described in the notice, to place a copy of the instructions for use in the file, and to notify all users of the issue with the software. The Siemens Service organization has coordinated the implementation of the field correction with the distributors for all countries. Non-responding consignees will be visited or called by telephone for follow up.
Quantity in Commerce 280 units
Distribution Worldwide Distribution --- including USA and countries of Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain (UK), Greece, Hong Kong, India, Italy, Jordan, Malaysia, Norway, Poland, Portugal, Romania, Russian Federation, Sweden, Switzerland, Thailand, and Turkey.