FDA-Device2014-11-26Class II
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Nidek Inc
Hazard
Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
Sold states
US Distribution in the states of: CA, NE, and NY.
Affected count
5
Manufactured in
47651 Westinghouse Dr, N/A, Fremont, CA, United States
Products
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0222-2015Don't want to check this manually?
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