Nidek Inc recalls MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus d…

Recall date

March 27, 2012

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1127-2015

FDA classification

Class II

Brand / firm

Nidek Inc

Sold / distributed

Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL.

Why it was recalled

The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.