Digisonics, DigiView and ERS software release 3.6.4.4 through 3.6.5.2+, 2008 Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098, 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-2180-2011 · Posted 2011-05-10
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Recalling FirmDigisonics, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2009-01-20
Date Terminated2011-05-31
Product Quantity70 units
Reason for Recall
Data from one patient's study had the potential for being put into another patient's report.
Firm Action
Digisonics notified end users via e-mail January 20, 2009 and January 21, 2009, that Data from one patient's study was being put into another patient's report. The problem occurred when a System bug was found in DigiView Release 3.6.4.4, and higher versions in which under certain circumstances
(specific workflow) a failure to switch to a patient's images occurs. Two software patch versions will be made available to sites on or after February 5, 2009, to correct the reported problem.
If you have any further questions, please contact Digisonics Customer Support at (800 ) 940-3240.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- USA including States of : OH, NC, LA, TX, CA, MO, NY, MD, MA, DC, IA, AZ, PA, MI, NC, FL, IN, SC, ID, MN, AR, OK, IL, CT, and countries of Canada, Lebanon, and New Zealand.
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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