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U.S. Department of Health and Human Services

Class 2 Device Recall OBLink release 2.0.7

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  Class 2 Device Recall OBLink release 2.0.7 see related information
Date Initiated by Firm May 12, 2008
Date Posted April 26, 2011
Recall Status1 Terminated 3 on May 02, 2011
Recall Number Z-2066-2011
Recall Event ID 58371
Product Classification Imager, ultrasonic obstetric gynecologic - Product Code HEM
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.
Code Information OB-Link version 2.0.7
Recalling Firm/
Manufacturer		 Digisonics, Inc
3701 Kirby Dr Ste 930
Houston TX 77098-3922
For Additional Information Contact
713-529-7979
Manufacturer Reason
for Recall		 Data/measurements from a OB report sent from ultrasound systems populated the wrong OB-View report
FDA Determined
Cause 2		 Other
Action Digisonics visited consignee in April 2008 as follow-up to complaint.
Quantity in Commerce 2 units
Distribution Nationwide Distribution including OK
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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