GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use i

FDA device recall Z-2120-2014 · posted 2014-08-13 · Terminated

Recall details

Recalling firm

Nidek Inc

Reason for recall

Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,

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).

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

GEX

Quantity affected

567 units

Distribution

USA (nationwide) Distribution

Date initiated

2014-05-16

Date posted

2014-08-13

Date terminated

2014-10-16

Location

Fremont, CA

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