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U.S. Department of Health and Human Services

Class 2 Device Recall MC500 Multicolor Laser Photocoagulator

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  Class 2 Device Recall MC500 Multicolor Laser Photocoagulator see related information
Date Initiated by Firm March 27, 2012
Date Posted February 19, 2015
Recall Status1 Terminated 3 on February 19, 2015
Recall Number Z-1127-2015
Recall Event ID 70335
510(K)Number K110228  
Product Classification Laser, ophthalmic - Product Code HQF
Product 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.
Code Information Serial numbers: 20023,20039, 20040, 20042, 20047, 20049, 20050, 20051, 20052, 20062, 20063, 20064, 20066, 20067, 20068, 20076
Recalling Firm/
Manufacturer		 Nidek Inc
47651 Westinghouse Dr
Fremont CA 94539-7474
For Additional Information Contact Neo Yamaguchi
510-353-7785
Manufacturer Reason
for Recall		 The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
FDA Determined
Cause 2		 Component design/selection
Action Nidek Japan issues a Engineering Change Order and Nidek reps visited affected sites to perform correction.
Quantity in Commerce 16 units in commerce
Distribution Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HQF and Original Applicant = NIDEK INCORPORATED
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