Company: Siemans- ACUSON Aspen Diagnostic Ultrasound System
Date of Enforcement Report 3/12/2008
Class:ll
PRODUCT
Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887, Recall # Z-0719-2008
REASON
Software error: Error affects all Aspen customer systems using the PAL video standard configuration and has 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 Reconstruction or FreeStyle extended imaging, FreeStyle compounding, or FreeStyle dynamic CDI technology).
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by Urgent Medical Device Notification on September 18, 2007. Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
242 units
DISTRIBUTION
Nationwide and Internationally
