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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 January 20, 2009
Date Posted May 10, 2011
Recall Status1 Terminated 3 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.
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 2		 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 and Original Applicant = DIGISONICS, INC.
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