Z-2113-2011

Doctors Review System, OB-Windows/OB-View software release numbers 4.1 through 4.1.3, Digisonics, Inc., 3701...

Name: Z-2113-2011 Doctors Review System, OB-Windows/OB-View software release numbers 4.1 through 4.1.3, Digisonics, Inc., 3701...
Creator: Digisonics, Inc
Published: 2007-02-09
License: https://open.fda.gov/license/

Digisonics, Inc / initiated 2007-02-09 / Terminated / root cause: software

FDA source

Digisonics, Inc began a recall of 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... on 2007-02-09. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2113-2011
Status: Terminated
Initiated: 2007-02-09
Posted: 2011-04-29
Terminated: 2011-05-02
Recalling firm: Digisonics, Inc
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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Other
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: [email protected].
Quantity in commerce: 128
Distribution: Worldwide distribution: USA (nationwide) and country of Canada.
Product codes and lots: Software release 4.1.3

Product code LLZ

K970402Class IIDoctors Review SystemDigisonics, Inc. / cleared 1997-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)