Optovue iVue with Normative Database — Class III medical device recall Z-1441-2013
Terminated recall by Optovue, Inc., reported 2013-06-12, distributed nationwide. Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3
| Recall number | Z-1441-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Optovue, Inc., Fremont, CA, United States |
| Recall initiated | 2013-05-14 |
| Classified | 2013-05-31 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2013-10-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 329 users |
Product
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1441-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.