Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model
FDA device recall Z-2067-2015 · posted 2015-07-14 · Terminated
Recall details
- Recalling firm
- Nidek Inc
- Reason for recall
- Accessories to the GYC-1000 laser were missing Laser Aperture labels.
- Action taken
- Nidek sent Recall Notifications to doctors on March 31, 2015, by Federal Express. Letters were specific to the accessory involved. NIDEK detected that the laser aperture label has not been affixed on the delivery unit of GYC-1000, Green Laser Photocoagulator System and the device does not meet FDA regulation 21 CFR Subchapter J. In order to comply with FDA regulation, Nidek requests that the customer affix the enclosed laser aperture label to the Dual Delivery 4DD-1 of GYC-1000, according to the instructions attached. Please see the enclosed Laser Aperture label, instruction for affixing to the device and the response card. Nidek requests that you complete and return the response card as soon as possible. For additional information, please call Nidek at 1-800-223-9044 or visit http://usa.nidek.com
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 22 units
- Distribution
- US Distribution to the states of : CA, IL, MN, MO, OR, IL, UT RI, MA, WA, NE, NY, NJ, TX and WI.
- Date initiated
- 2015-03-25
- Date posted
- 2015-07-14
- Date terminated
- 2015-07-14
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT (K133358) | Nidek Co., Ltd. | 2014-08-12 |
| GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 (K032085) | Nidek, Inc. | 2003-10-03 |