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Nidek Inc recalls Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and ant
Recalled July 9, 2014 · FDA recall Z-1980-2014 · Nidek
Hazard
Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. · FDA Class II
Units
185 cameras
Sold at
Nationwide Distribution.
Description
Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
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.
Manufacturer(s)
Nidek Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →