FDAClass IIJuly 22, 2015

Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green recall

Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser…

Why was Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green recalled?

Accessories to the GYC-1000 laser were missing Laser Aperture labels.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model GYC4EP-01 0W02 and GYC4EP-1 0Z20;

Product
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser…
Recalling firm
Nidek Inc
Quantity
W020 - 1 unit; 0Z20- 6 units
Distribution
US Distribution to the states of : CA, IL, MN, MO, OR, IL, UT RI, MA, WA, NE, NY, NJ, TX and WI.
Recall date
July 22, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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