Z-2066-2011

OB-Link release 2.0.7. distributed by Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098 OBLink provides...

Name: Z-2066-2011 OB-Link release 2.0.7. distributed by Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098 OBLink provides...
Creator: Digisonics, Inc
Published: 2008-05-12
License: https://open.fda.gov/license/

Digisonics, Inc / initiated 2008-05-12 / Terminated

FDA source

Digisonics, Inc began a recall of OB-Link release 2.0.7. distributed by Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098 OBLink provides automated transmission of patient data and... on 2008-05-12. The reason FDA records is "Data/measurements from a OB report sent from ultrasound systems populated the wrong OB-View report". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2066-2011
Status: Terminated
Initiated: 2008-05-12
Posted: 2011-04-26
Terminated: 2011-05-02
Recalling firm: Digisonics, Inc
Product: OB-Link release 2.0.7. distributed by Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098 OBLink provides automated transmission of patient data and measurements from ultrasound systems directly to Digisonics OB-View/OB-Windows systems.
Product code: HEM Imager, Ultrasonic Obstetric-Gynecologic
Reason for recall: Data/measurements from a OB report sent from ultrasound systems populated the wrong OB-View report
FDA root cause: Other
Action: Digisonics visited consignee in April 2008 as follow-up to complaint.
Quantity in commerce: 2 units
Distribution: Nationwide Distribution including OK
Product codes and lots: OB-Link version 2.0.7

Product code HEM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)