Recall Z-2166-2011 ยท LLZ System, Image Processing, Radiological
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.
| Date | May 10, 2011 (initiated Nov 4, 2008) |
| Status | Terminated |
| Reason | Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 70 units total |
| Distribution | Worldwide Distribution -- USA including States of : TX, OH, NC, MA, NY, IL, FL, OK, MO, ID, AZ, AR, MI CA, MD, and country of Canada. *** Due to the age of this recall, district is recommending no audit checks*** |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970402 | DOCTORS REVIEW SYSTEM Digisonics, Inc., Mar 26, 1997 |