Recall Z-1441-2013 ยท HLI Ophthalmoscope, Ac-Powered
Optovue, Inc.
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
| Date | May 31, 2013 (initiated May 14, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | ~329 users |
| Distribution | Distributed Nationwide and in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121739 | IVUE WITH NORMATIVE DATABASE Optovue, Inc., Jan 18, 2013 |