OB-Link release 2.0.7. distributed by Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098 OBLink provides automated tra
FDA device recall Z-2066-2011 · posted 2011-04-26 · Terminated
Recall details
- Recalling firm
- Digisonics, Inc
- Reason for recall
- Data/measurements from a OB report sent from ultrasound systems populated the wrong OB-View report
- Action taken
- Digisonics visited consignee in April 2008 as follow-up to complaint.
- Root cause
- Other
- Status
- Terminated
- Product code
- HEM
- Quantity affected
- 2 units
- Distribution
- Nationwide Distribution including OK
- Date initiated
- 2008-05-12
- Date posted
- 2011-04-26
- Date terminated
- 2011-05-02
- Location
- Houston, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.