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U.S. Department of Health and Human Services

Class 2 Device Recall DigiView software

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  Class 2 Device Recall DigiView software see related information
Date Initiated by Firm November 04, 2008
Date Posted May 10, 2011
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = DIGISONICS, INC.
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