14
Mar
2008

Siemans-ACUSON Aspen Diagnostic Ultrasound Cl II

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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