FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2066-2011
- Recalling firm
- Digisonics, Inc
- 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.
- Status
- Terminated
- Initiated
- 2008-05-12
- Posted
- 2011-04-26
- Terminated
- 2011-05-02
- 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
- Lot, serial or model codes
- OB-Link version 2.0.7
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HEM
- Firm FEI
- 1626313
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28