Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1980-2014 — 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.

U.S. FDA — Device Enforcement · United States · 2014-06-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1980-2014
Date of alert
2014-06-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Nidek Inc
Product category
device
Product type
Devices
Reported risk: Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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