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.
This recall has been terminated (originally issued April 29, 2011).
- Company
- Digisonics, Inc
- Recall Initiated
- February 9, 2007
- Posted
- April 29, 2011
- Terminated
- May 2, 2011
- Recall Number
- Z-2113-2011
- Quantity
- 128
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution: USA (nationwide) and country of Canada.
Lot / Code Info
Software release 4.1.3
Root Cause
Other
Action Taken
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.