Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
FDA device recall Z-1441-2013 · posted 2013-05-31 · Terminated
Recall details
- Recalling firm
- Optovue, Inc.
- Reason for recall
- Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports.
- Action taken
- Optovue sent a Field Correction Notice letter dated May 16, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HLI
- Quantity affected
- ~329 users
- Distribution
- Distributed Nationwide and in Canada.
- Date initiated
- 2013-05-14
- Date posted
- 2013-05-31
- Date terminated
- 2013-10-24
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IVUE WITH NORMATIVE DATABASE (K121739) | Optovue, Inc. | 2013-01-18 |