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/ Manufacturer |
Nidek Inc 47651 Westinghouse Dr Fremont CA 94539-7474
|
For Additional Information Contact |
Neo Yamaguchi 510-353-7785
|
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
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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.
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PMA Database |
PMAs with Product Code = LZS and Original Applicant = NIDEK CO., LTD.
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