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Nidek Inc recalls MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in
Recalled August 6, 2014 · FDA recall Z-2132-2014 · Nidek
Hazard
Laser aperture label was not affixed to device prior to shipment in the US. · FDA Class II
Units
29 units (26 already re-labeled)
Sold at
Nationwide Distribution including IL NE NY, NH, CD, MI, TX, CA, PA, FL, KS, UT, MN, WI,. MO. and OR.
Description
Laser aperture label was not affixed to device prior to shipment in the US.
Product
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
Manufacturer(s)
Nidek Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →