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.
FDA Recall Z-1127-2015 · Posted 2015-02-19
Recalling FirmNidek Inc
Recall StatusTerminated
Product CodeHQF
Date Initiated2012-03-27
Date Terminated2015-02-19
Product Quantity16 units in commerce
Reason for Recall
The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
Firm Action
Nidek Japan issues a Engineering Change Order and Nidek reps visited affected sites to perform correction.
Root Cause
Component design/selection
Distribution Pattern
Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.