Z-2068-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2015
- Initiation Date
- March 25, 2015
- Termination Date
- July 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- W020 - 1 unit; 0Z20- 6 units
Product Description
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; 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 for Recall
Accessories to the GYC-1000 laser were missing Laser Aperture labels.
Distribution Pattern
US Distribution to the states of : CA, IL, MN, MO, OR, IL, UT RI, MA, WA, NE, NY, NJ, TX and WI.
Code Information
Model GYC4EP-01 0W02 and GYC4EP-1 0Z20;