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Nidek Inc recalls MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation
Recalled November 26, 2014 · FDA recall Z-0222-2015 · Nidek
Hazard
Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required. · FDA Class II
Units
5
Sold at
US Distribution in the states of: CA, NE, and NY.
Description
Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
Product
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Manufacturer(s)
Nidek Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →