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U.S. Department of Health and Human Services

Class 2 Device Recall Nidek Excimer Laser Corneal Surgery System, model EC5000 CXIII.

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  Class 2 Device Recall Nidek Excimer Laser Corneal Surgery System, model EC5000 CXIII. see related information
Date Initiated by Firm August 06, 2012
Date Posted November 17, 2014
Recall Status1 Terminated 3 on November 17, 2014
Recall Number Z-0223-2015
Recall Event ID 69508
PMA Number P970053 
Product Classification Excimer laser system - Product Code LZS
Product Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII.
Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
Code Information Serial numbers: 530054 530055 530070 530073 530078 530082 530086 530087 530098 530106 530121 530123 530150 530155 
Recalling Firm/
Nidek Inc
47651 Westinghouse Dr
Fremont CA 94539-7474
For Additional Information Contact Neo Yamaguchi
Manufacturer Reason
for Recall
Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the patient.
FDA Determined
Cause 2
Component design/selection
Action Nidek Engineers visited each site to perform correction - fuse holders have been inspected and replaced if necessary. An Engineering Change Order was issued on June 1, 2012, for inspection and/or replacement of affected fuse holders by Nidek Service Engineers. For further questions please call (510) 353-7785.
Quantity in Commerce 14 units
Distribution US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT 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.
PMA Database PMAs with Product Code = LZS and Original Applicant = NIDEK CO., LTD.