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.
FDA Recall Z-2166-2011 · Posted 2011-05-10
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Recalling FirmDigisonics, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2008-11-04
Date Terminated2011-05-31
Product Quantity70 units total
Reason for Recall
Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed.
Firm 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 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.
Root Cause
Device Design
Distribution Pattern
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***
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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