Class 2 Device Recall MC500 Multicolor Laser Photocoagulator

• Date Initiated by Firm: May 24, 2013
• Date Posted: November 17, 2014
• Recall Status: Terminated 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: 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