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U.S. Department of Health and Human Services

Class 2 Device Recall NonMydriatic Auto Fundus Camera Model AFC330

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  Class 2 Device Recall NonMydriatic Auto Fundus Camera Model AFC330 see related information
Date Initiated by Firm June 16, 2014
Date Posting Updated July 02, 2014
Recall Status1 Terminated 3 on March 03, 2015
Recall Number Z-1980-2014
Recall Event ID 68234
510(K)Number K113451  
Product Classification Camera, ophthalmic, ac-powered - Product Code HKI
Product Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye.

Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.
Code Information Model AFC-330:, Serial numbers:, 380034, 380021, 380035, 380061, 380060, 380013, 380011, 380069, 380073, 380053, 380055, 380067, 380077, 380078, 380017, 380075, 380032, 380080, 380081, 380092, 380116, 380120, 380237, 380238, 380239, 380240, 380241, 380122, 380121, 380014, 380211, 380125, 380126, 380127, 380124, 380215, 380214, 380188, 380221, 380187, 380190, 380189, 380212, 380062, 380038, 380128, 380223, 380224, 380076, 380216, 380213, 380222, 380243, 380054, 380042, 380225, 380244, 380251, 380252, 380256, 380015, 380250, 380074, 380018, 380012, 380258, 380068, 380260, 380186, 380037, 380253, 380264, 380242, 380261, 380262, 380123, 380255, 380016, 380052, 380033, 380257, 380259, 380004, 380009, 380019, 380023, 380027, 380029, 380099, 380101, 380103, 380108, 380118, 380131, 380134, 380139, 380144, 380146, 380147, 380148, 380152, 380153, 380155, 380156, 380157, 380159, 380160, 380162, 380164, 380175, 380177, 380178, 380185, 380196, 380198, 380201, 380203, 380207, 380208, 380218, 380219, 380236, 380008, 380020, 380043, 380056, 380058, 380063, 380066, 380070, 380071, 380088, 380090, 380098, 380102, 380105, 380106, 380107, 380111, 380112, 380115, 380117, 380119, 380129, 380130, 380136, 380140, 380141, 380142, 380143, 380145, 380150, 380158, 380163, 380176, 380179, 380180, 380181, 380182, 380183, 380184, 380199, 380200, 380202, 380205, 380209, 380210, 380226, 380227, 380228, 380230, 380232, 380233, 380234, 380235, 380265, 380267, 380268, 380269, 380270, 380271, 380272, 380273, 380274, 380275..
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
Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
FDA Determined
Cause 2
Device Design
Action Field Correction notifications were sent to all affected users on June 16, 2014 by trackable method.
Quantity in Commerce 185 cameras
Distribution Nationwide Distribution.
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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