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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 Posted July 02, 2014
Recall Status1 Terminated 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HKI and Original Applicant = NIDEK TECHNOLOGIES SRL
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