Digisonics, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Digisonics, Inc
Lot Codes / Batch Numbers
Software release 4.1.3
Products Sold
Software release 4.1.3
Digisonics, Inc is recalling Doctors Review System, OB-Windows/OB-View software release numbers 4.1 through 4.1.3, Digisonics, In due to 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 d. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026