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U.S. Department of Health and Human Services

Class 2 Device Recall EC5000 Excimer Laser Corneal Surgery System

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  Class 2 Device Recall EC5000 Excimer Laser Corneal Surgery System see related information
Date Initiated by Firm March 24, 2015
Date Posted June 04, 2015
Recall Status1 Terminated 3 on April 05, 2016
Recall Number Z-1710-2015
Recall Event ID 71098
PMA Number P970053 
Product Classification Excimer laser system - Product Code LZS
Product EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest.

Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.
Code Information Alll devices currently in use by consignees.
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		 Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
FDA Determined
Cause 2		 No Marketing Application
Action Nidek sent an Device Correction letter dated April 30th, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Nidek will contact customers to schedule an appointment to replace the operators manual and implementing a software lockout device on the device so that the multi stage feature is no longer available. If a Nidek rep does not contact you before April 30, 2015, please call 800-223-9044 to schedule an appointment, All non responding customers.will be contacted three time via Fed Ex letter
Quantity in Commerce 114 units
Distribution Us distribution only.
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.
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