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U.S. Department of Health and Human Services

Class 2 Device Recall Nidek MC500 Multicolor Laser Photocoagulator

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  Class 2 Device Recall Nidek MC500 Multicolor Laser Photocoagulator see related information
Date Initiated by Firm October 24, 2012
Date Posted November 17, 2014
Recall Status1 Terminated 3 on November 17, 2014
Recall Number Z-0224-2015
Recall Event ID 69537
510(K)Number K110228  
Product Classification Laser, ophthalmic - Product Code HQF
Product Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20.
Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.
Code Information Model MC-500 Serial numbers:  50277 50310 50330 50331 50357 50358 50383 50408 50417 50418 50425 50426 50439 50440 50445 50446 50471 50514 50311 50359 50382, 
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		 When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program.
FDA Determined
Cause 2		 Device Design
Action Nidek Field Service engineers visited each affected location to upgrade software.
Quantity in Commerce 21affected devices
Distribution US Distribution in the states of: NJ, SC, IL, MI, NY, CA, TX, OH, IN, UT, and MN.
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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