FDA Device recall Z-1980-2014
Non-Mydriatic Auto Fundus Camera
- FDA Device
- Class II
- terminated
- Published 2014-07-09
On 2014-07-09 the FDA classified a Class II recall of Non-Mydriatic Auto Fundus Camera by Nidek, citing image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1980-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-16 |
| Published | 2014-07-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nidek |
| Distribution | US |
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.
Reason
Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
Identifiers
| code_info | Model AFC-330: Serial numbers: 380034 380021 380035 380061 380060 380013 380011 380069 380073 380053 380055…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1980-2014%22
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