Nidek GYC-1000 Green Laser Photocoagulator Recalled for Missing Aperture Label
Nidek Inc is recalling 567 GYC-1000 Green Laser Photocoagulator systems because the required laser aperture label was not applied to the devices.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a missing label, which is a documentation and packaging issue. No injuries, illnesses, or functional defects are reported in the source text.
Plain-English summary
Nidek Inc is recalling 567 units of the GYC-1000 Green Laser Photocoagulator system. The recall was initiated because the laser aperture label was not applied to certain devices in the field as required by FDA regulations.
The GYC-1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy, and trabeculoplasty. The affected devices were distributed nationwide in the United States. Specific serial numbers for the affected units are listed in the official recall record.
Healthcare facilities and users of these devices should stop using the affected units and contact Nidek Inc for further instructions regarding the recall and corrective actions.
The recalled product
- 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.
- Manufacturer
- Nidek Inc
- Hazard
- Affected units
- 567
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model: GYC-1000
Distribution
Distributed nationwide across the United States.
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