Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall OBLink release 2.0.7

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall OBLink release 2.0.7see related information
Date Initiated by FirmMay 12, 2008
Date PostedApril 26, 2011
Recall Status1 Terminated 3 on May 02, 2011
Recall NumberZ-2066-2011
Recall Event ID 58371
Product Classification Imager, ultrasonic obstetric gynecologic - Product Code HEM
ProductOB-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
ActionDigisonics visited consignee in April 2008 as follow-up to complaint.
Quantity in Commerce2 units
DistributionNationwide Distribution including OK
Total Product Life CycleTPLC 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.
-
-