Recall Z-2120-2014
Nidek Inc · initiated May 16, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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 10568 10569 10570 10571 10572 10573 10594 10595 10596 10597 10598 10599 10600 10608 10609 10610 10611 10612 10613 10614 10615 10616 10651 10652 10653 10654 10655 10673 10674 10675 10676 10677 10678 10679 10680 10696 10697 10732 10766 10767 10768 10769 10770 10771 10772 10773 10798 10799 10800 10801 10802 10821 10822 10823 10824 10825…
Reason for recall
Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,
FDA-determined cause: Radiation Control for Health and Safety Act
Action taken
Nidek sent an Medical Device Correction Notifications dated May 16, 2014, informing doctors of the lack of the Laser Aperture Label for GYC-1000 Green Laser Photocoagulator System. Letters included a Aperture label and instruction/illustration on where to affix it to the device. A response form is to be completed and returned indicating that they read the correction information and have affixed the label on the GYC-1000 device as instructed. Questions may be directed to Nidek Customer service at 1-800-223-9044 Monday - Friday from 8 am to 5 pm PST. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. You may proceed or continue with implementation of the CAP (subject to the conditions noted above).
Details
- Recall number
- Z-2120-2014
- Initiated
- May 16, 2014
- Posted by FDA
- August 13, 2014
- Terminated
- October 16, 2014
- Product code
- GEX – Powered Laser Surgical Instrument
- Quantity
- 567 units
- Distribution
- USA (nationwide) Distribution
- Recalling firm
- Nidek Inc, Fremont, CA