Company: Siemens Medical Solutions, USA, Inc
Date of Enforcement Report:7/26/2006
Class:lIl
PRODUCT
KinetDx 4.0 Ultrasound Image Management System, Recall # Z-1235-06
REASON
The cardiologist’s report comments may not be retained by the system due to a software bug..
CODE
All units with software versions 4.0 and 4.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions, USA, Inc., Ann Arbor, MI, by visits in April 2006.
Manufacturer: Siemens Medical Solutions, USA, Inc., Malvern, PA.Firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
244 systems
DISTRIBUTION
Nationwide