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

Recall Z-2046-2013 — 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.

U.S. FDA — Device Enforcement · United States · 2013-08-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2046-2013
Date of alert
2013-08-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Nidek Inc
Product category
device
Product type
Devices
Reported risk: Under certain circumstances, the Left eye image may be saved as the Right eye 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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