Devices

Device Recall NonMydriatic Auto Fundus Camera Model AFC330

Model / Serial
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.
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
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.
Manufacturer
Nidek Inc
1 Event
- Recall of Device Recall NonMydriatic Auto Fundus Camera Model AFC330

Manufacturer

Nidek Inc

Manufacturer Address
Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
Manufacturer Parent Company (2017)
Nidek Co. Ltd.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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