Recall Z-2066-2011 ยท HEM Imager, Ultrasonic Obstetric-Gynecologic
Digisonics, Inc
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.
| Date | Apr 26, 2011 (initiated May 12, 2008) |
| Status | Terminated |
| Reason | Data/measurements from a OB report sent from ultrasound systems populated the wrong OB-View report |
| Root cause | Other |
| Action | Digisonics visited consignee in April 2008 as follow-up to complaint. |
| Quantity | 2 units |
| Distribution | Nationwide Distribution including OK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.