Company:Digisonics, Inc.
Date of Enforcement Report 5/25/2011
Class ll:
PRODUCT
DigiView software release 3.4.4.4 through 3.5.5.2. Digiview is a digital image management and reporting system with an associated clinical database. It provides capture, review and storage of images together with report creation and data basing. Recall # Z-2166-2011
REASON
Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed.
RECALLING FIRM/MANUFACTURER
Digisonics, Inc., Houston, TX, by telephone and e-mail on October 17, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
70 units
DISTRIBUTION
Nationwide and Canada
