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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 June 09, 2014
Date Posted July 30, 2014
Recall Status1 Terminated 3 on November 24, 2014
Recall Number Z-2132-2014
Recall Event ID 68766
510(K)Number K110228  
Product Classification Laser, ophthalmic - Product Code HQF
Product MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
Code Information Part number: 173530U20 Serial numbers: 50010, 50127, 50136, 50277, 50310, 50311, 50330, 50331, 50357. 50358, 50359, 50382, 50383, 50408. 50417, 50418, 50426, 50439, 50445, 50446, 50471, 50514, 50552, 50558, 50573, 50600, 50610, 50611, 50651.
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		 Laser aperture label was not affixed to device prior to shipment in the US.
FDA Determined
Cause 2		 Error in labeling
Action Nidek sent a Recall/Field Correction letter dated June 9, 2014, to all affected customers. The letter advised customers of the issues and informed customers that Nidek Representatives will visit each location to affix the proper labeling to the device. Customers with questions were instructed to contact Nidek Customer Service at 1-800-223-9044 M-F 8 am to 5 pm PST. For questions regarding this recall call 510-353-7785.
Quantity in Commerce 29 units (26 already re-labeled)
Distribution Nationwide Distribution including IL NE NY, NH, CD, MI, TX, CA, PA, FL, KS, UT, MN, WI,. MO. and OR.
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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