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U.S. Department of Health and Human Services

Class 2 Device Recall NAVISEX

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  Class 2 Device Recall NAVISEX see related information
Date Initiated by Firm August 01, 2013
Date Posted August 23, 2013
Recall Status1 Terminated 3 on February 25, 2014
Recall Number Z-2046-2013
Recall Event ID 65865
510(K)Number K113451  
Product Classification Camera, ophthalmic, ac-powered - Product Code HKI
Product NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.
Code Information version 1.1.0; serial numbers: 320823 320425 320622 121424 320094 320606 320617 320577 320636 320630 320468 320489 320518 320695 320695 320652 320666 320692 320675 320640 320492 320695 320704 320777 320779 320771 320768 320753 320744 320780 320617; version 1.2.1; serial numbers 320740 120045; Version 1.3.0: 141356 320814 320815 140941 141326 320847 320916 320906 320203 320569 320809 320813 141357 320831 140937 141358 320798 320090 320980 320990 320927 320942 320920 141401 320983; Version 1.3.4; 321035 321020 320998 141453; Version 1.3.5: 380215 380188 380189 380251 380211 380014 380077 380213 380076 380034 380035 380017 380244 380124 380243 380075 380122 380021 380253/380052 380221/380214 141480 141471 321053 320883.    
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		 Under certain circumstances, the Left eye image may be saved as the Right eye image.
FDA Determined
Cause 2		 Software design
Action "Medical Device Correction Notification" letters dated August 5, 2013 were sent to consignees through their US contracted distributor - Marco Opthalmic. The letter described the product issue and provided information on the correction. Customers can contact 800-223-9044 for questions.
Quantity in Commerce 86
Distribution Nationwide 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.
510(K) Database 510(K)s with Product Code = HKI and Original Applicant = NIDEK TECHNOLOGIES SRL
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