Digisonics, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Digisonics, Inc
Lot Codes / Batch Numbers
DigiView Rel. 3.6.4.4, 3.6.4.6, and 3.6.5.2.
Products Sold
DigiView Rel. 3.6.4.4, 3.6.4.6, and 3.6.5.2.
Digisonics, Inc is recalling Digisonics, DigiView and ERS software release 3.6.4.4 through 3.6.5.2+, 2008 Digisonics, Inc., 3701 due to Data from one patient's study had the potential for being put into another patient's report.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Data from one patient's study had the potential for being put into another patient's report.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, CA, CT, FL, ID, IL, IN, IA, LA, MD, MA, MI, MN, MO, NY, NC, OH, OK, PA, SC, TX, DC
Page updated: Jan 10, 2026