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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 May 24, 2013
Date Posted November 17, 2014
Recall Status1 Terminated 3 on November 17, 2014
Recall Number Z-0222-2015
Recall Event ID 69531
510(K)Number K110228  
Product Classification Laser, ophthalmic - Product Code HQF
Product MC-500 Multicolor Laser Photocoagulator using software version 2.20.
Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Code Information MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609
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		 Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
FDA Determined
Cause 2		 Software design
Action Nidek Engineers visited all affected sites to install new software version. For questions regarding this recall call 510-353-7785.
Quantity in Commerce 5
Distribution US Distribution in the states of: CA, NE, and NY.
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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