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Nidek Inc recalls 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
Recalled September 4, 2013 · FDA recall Z-2046-2013 · Nidek
Hazard
Under certain circumstances, the Left eye image may be saved as the Right eye image. · FDA Class II
Units
86
Sold at
Nationwide US distribution only.
Description
Under certain circumstances, the Left eye image may be saved as the Right eye image.
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.
Manufacturer(s)
Nidek Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →