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.
This recall has been terminated (originally issued May 10, 2011).
- Company
- Digisonics, Inc
- Recall Initiated
- January 20, 2009
- Posted
- May 10, 2011
- Terminated
- May 31, 2011
- Recall Number
- Z-2180-2011
- Quantity
- 70 units
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Data from one patient's study had the potential for being put into another patient's report.
Distribution
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.
Lot / Code Info
DigiView Rel. 3.6.4.4, 3.6.4.6, and 3.6.5.2.
Root Cause
Device Design
Action Taken
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.