Doctors Review System, OB-Windows/OB-View software release numbers 4.1 through 4.1.3, Digisonics, Inc., 3701 Kirby Drive
FDA device recall Z-2113-2011 · posted 2011-04-29 · Terminated
Recall details
- Recalling firm
- Digisonics, Inc
- Reason for recall
- Study would on occasion have fetal heart rate and/or cervical length on the report that was not entered nor did it belong to that patient. Software displayed incorrect data for fetal heart rate and cervical length in OB ultrasound reports.
- Action taken
- The firm, Digisonics Inc, notified the affected customers of software release via e-mail on January 24, 2007 and follow-up e-mail on February 7, 2007. The e-mails described the product, problem and the actions taken. The firm was able to trap the error and after this report the developer was able to determine the cause and a new executable was sent and installed at the customers site. If you have any question, please call 800-940-3240 or e-mail: service@digison.net.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 128
- Distribution
- Worldwide distribution: USA (nationwide) and country of Canada.
- Date initiated
- 2007-02-09
- Date posted
- 2011-04-29
- Date terminated
- 2011-05-02
- Location
- Houston, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DOCTORS REVIEW SYSTEM (K970402) | Digisonics, Inc. | 1997-03-26 |