Digisonics, Inc DigiView software release 3.4.4.4 through 3.5.5.2. , 2008 Digisonics, Inc, 800-940-3240. 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

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed.

Recommended Action

Per FDA guidance

Digisonics, Inc., notified consignees by telephone and e-mail on 10/17/2008, informing them that a problem had been found in the Save Linked Images functionality of DigiView Release 3.6 (and all releases which start with 3.6 such as 3.6.1.). The problem is the failure of the software to update some measurements when tracings or points are amended after measurement calculations have been performed. A utility program, called Linked Image Measurement Verify was being supplied to all sites as a patch to the DigiView program. Release 3.6.6 was to be provided to all customers having previous 3.6 version. Problem was fixed in version 3.6.6 and 3.7.1. If you have any questions, please contact Digisonics Customer Support at (800) 940-3240.

Distribution

As reported by FDA

AZ, AR, CA, FL, ID, IL, MD, MA, MI, MO, NY, NC, OH, OK, TX