Class 2 Device Recall DigiView software

• Date Initiated by Firm: January 20, 2009
• Date Posted: May 10, 2011
• Recall Status: Terminated on May 31, 2011
• Recall Number: Z-2180-2011
• Recall Event ID: 58395
• 510(K)Number: K970402
• Product Classification: system, image processing, radiological - Product Code LLZ
• 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.
• Code Information: DigiView Rel. 3.6.4.4, 3.6.4.6, and 3.6.5.2.
• FEI Number: 1626313
• Recalling Firm/ Manufacturer: Digisonics, Inc; 3701 Kirby Dr Ste 930; Houston TX 77098-3922
• For Additional Information Contact: 713-529-7979
• Manufacturer Reason for Recall: Data from one patient's study had the potential for being put into another patient's report.
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 70 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = LLZ