Class 2 Device Recall DigiView software

• Date Initiated by Firm: November 04, 2008
• Date Posted: May 10, 2011
• Recall Status: Terminated on May 31, 2011
• Recall Number: Z-2166-2011
• Recall Event ID: 58400
• 510(K)Number: K970402
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: 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.
• Code Information: DigiView software release numbers 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: Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed.
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 70 units total
• Distribution: 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***
• 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