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U.S. Department of Health and Human Services

Class 2 Device Recall DigiView software

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 Class 2 Recall
DigiView software
see related information
Date Posted May 10, 2011
Recall Status1 Terminated on May 31, 2011
Recall Number Z-2180-2011
Recall Event ID 58395
Premarket Notification
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.
Recalling Firm/
Manufacturer
Digisonics, Inc
3701 Kirby Dr Ste 930
Houston, Texas 77098-3922
Manufacturer Reason
for Recall
Data from one patient's study had the potential for being put into another patient's report.
FDA Determined
Cause 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = DIGISONICS, INC.
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