NAVIS-EX — Class II medical device recall Z-2046-2013
Terminated recall by Nidek Inc, reported 2013-09-04, distributed nationwide. Under certain circumstances, the Left eye image may be saved as the Right eye image.
| Recall number | Z-2046-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek Inc, Fremont, CA, United States |
| Recall initiated | 2013-08-01 |
| Classified | 2013-08-23 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2014-02-25 |
| Distributed | Nationwide (US) |
| Quantity | 86 |
| Serial numbers | 120045, 121424, 320094, 320425, 320468, 320489, 320492, 320518, 320577, 320606, 320617, 320622, 320630, 320636, 320640, 320652, 320666, 320675, 320692, 320695, 320704, 320740, 320744, 320753, 320768 and 5 more |
Product
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.
Reason for recall
Under certain circumstances, the Left eye image may be saved as the Right eye image.
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-2046-2013. 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.