Non-Mydriatic Auto Fundus Camera — Class II medical device recall Z-1980-2014
Terminated recall by Nidek Inc, reported 2014-07-09, distributed nationwide. Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
| Recall number | Z-1980-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek Inc, Fremont, CA, United States |
| Recall initiated | 2014-06-16 |
| Classified | 2014-07-02 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2015-03-03 |
| Distributed | Nationwide (US) |
| Quantity | 185 cameras |
| Serial numbers | 380004, 380008, 380009, 380011, 380012, 380013, 380014, 380015, 380016, 380017, 380018, 380019, 380020, 380021, 380023, 380027, 380029, 380032, 380033, 380034, 380035, 380037, 380038, 380042, 380043 and 160 more |
| Model numbers | AFC-330 |
Product
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.
Reason for recall
Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of 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-1980-2014. 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.