FDA Device recall Z-2120-2014
GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgic…
- FDA Device
- Class II
- terminated
- Published 2014-08-20
On 2014-08-20 the FDA classified a Class II recall of GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgic… by Nidek, citing laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2120-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-16 |
| Published | 2014-08-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nidek |
| Distribution | US |
Product
GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Reason
Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,
Identifiers
| code_info | Model: GYC-1000; Serial numbers: 10018 10039 10040 10041 10042 10043 10044 10045 10046 10047 10048 10063…Model: GYC-1000; Serial numbers: 10018 10039 10040 10041 10042 10043 10044 10045 10046 10047 10048 10063 10064 10066 10067 10068 10072 10073 10074 10075 10079 10080 10081 10082 10083 10084 10085 10086 10087 10088 10108 10109 10110 10111 10112 10113 10114 10115 10116 10117 10146 10147 10148 10149 10150 10151 10152 10153 10154 10155 10162 10208 10209 10212 10213 10222 10225 10226 10238 10239 10242 10243 10244 10245 10272 10273 10274 10275 10276 10295 10296 10297 10298 10299 10300 10301 10302 10303 10304 10328 10329 10330 10331 10332 10333 10334 10335 10336 10337 10356 10357 10358 10359 10360 10361 10362 10363 10364 10365 10366 10367 10400 10401 10402 10403 10404 10405 10406 10429 10430 10431 10432 10433 10459 10461 10464 10465 10466 10491 10492 10493 10494 10537 10538 10539 10540 10541 10542 10543 10544 10545 10546 10547 10548 10549 10550 10566 10567 |
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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-2120-2014%22
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