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U.S. Department of Health and Human Services

Class 2 Device Recall DOCTORS REVIEW SYSTEM

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 Class 2 Recall
DOCTORS REVIEW SYSTEM
see related information
Date Posted April 29, 2011
Recall Status1 Terminated on May 02, 2011
Recall Number Z-2113-2011
Recall Event ID 58367
Premarket Notification
510(K) Number
K970402 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Doctors Review System, OB-Windows/OB-View software release numbers 4.1 through 4.1.3, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098 OB-Windows provides professional reporting and analysis of fetal growth throughout the gestational period, which can help evaluate clinical situations. OB-View provides image management for the user to capture, view, read, and edit images.
Code Information Software release 4.1.3
Recalling Firm/
Manufacturer
Digisonics, Inc
3701 Kirby Dr Ste 930
Houston, Texas 77098-3922
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Study would on occasion have fetal heart rate and/or cervical length on the report that was not entered nor did it belong to that patient. Software displayed incorrect data for fetal heart rate and cervical length in OB ultrasound reports.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action The firm, Digisonics Inc, notified the affected customers of software release via e-mail on January 24, 2007 and follow-up e-mail on February 7, 2007. The e-mails described the product, problem and the actions taken. The firm was able to trap the error and after this report the developer was able to determine the cause and a new executable was sent and installed at the customers site. If you have any question, please call 800-940-3240 or e-mail: service@digison.net.
Quantity in Commerce 128
Distribution Worldwide distribution: USA (nationwide) and country of Canada.
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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