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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 Device Recall Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5see related information
Date Initiated by FirmFebruary 06, 2009
Date PostedMay 13, 2011
Recall Status1 Terminated 3 on May 31, 2011
Recall NumberZ-2193-2011
Recall Event ID 58421
510(K)NumberK970402 
Product Classification System, image processing, radiological - Product Code LLZ
ProductDigisonics, 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
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		Left ventricle volume was inaccurate when the volumes were measured from images having different scales.
FDA Determined
Cause 2		Other
ActionThe 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 Commerce74 units
DistributionWorldwide distribution: USA (Nationwide) and countries of: Canada, Lebanon and New Zealand.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
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