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U.S. Department of Health and Human Services

Class 2 Device Recall Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5

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 Class 2 Recall
Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5
see related information
Date Posted May 13, 2011
Recall Status1 Terminated on May 31, 2011
Recall Number Z-2193-2011
Recall Event ID 58421
Premarket Notification
510(K) Number
K970402 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098, Tel: (800) 940-3240, Fax: (713) 529-7999 Software used to make on-screen (2-D, M-Mode and Doppler) measurements of left ventricle, right ventricle, etc.
Code Information DigiView software release numbers 3.6.44, 3.6.4.6, and 3.6.5
Recalling Firm/
Manufacturer
Digisonics, Inc
3701 Kirby Dr Ste 930
Houston, Texas 77098-3922
Manufacturer Reason
for Recall
Left ventricle volume was inaccurate when the volumes were measured from images having different scales.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action The firm, Digisonics, notified consignees/customers via e-mail entitled "Distribution of Notification of Biplane Error" dated February 6, 2009. The email described the product, problem and actions to be taken. The customers were instructed to immediately contact Digisonics if their site calculates biplane volumes-a utility will be provided which will run on their database and identify all studies in which biplane volumes are calculated. The customers were also instructed to share the following important information with all users of DigiView at their site. The email stated -until the software patch has been installed, biplane volumes should be calculated only from pairs of images having the same depth scale. Replacement DigiView/ERS software that prevents further occurrence of this problem will be provided if it appears their site could be impacted. The Distribution of New Software Release was sent on March 6, 2009. If you have any questions, please call Digisonics Customer Support at 800-344-4266.
Quantity in Commerce 74 units
Distribution Worldwide distribution: USA (Nationwide) 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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