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.
FDA Recall Z-2066-2011 · Posted 2011-04-26
Recalling FirmDigisonics, Inc
Recall StatusTerminated
Product CodeHEM
Date Initiated2008-05-12
Date Terminated2011-05-02
Product Quantity2 units
Reason for Recall
Data/measurements from a OB report sent from ultrasound systems populated the wrong OB-View report
Firm Action
Digisonics visited consignee in April 2008 as follow-up to complaint.
Root Cause
Other
Distribution Pattern
Nationwide Distribution including OK
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.