Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device Recalled by Nidek Inc Due to Retrospective review found that a Engineering Change Order...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nidek Inc directly.
Affected Products
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Quantity: 5
Why Was This Recalled?
Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
Where Was This Sold?
This product was distributed to 3 states: CA, NE, NY
About Nidek Inc
Nidek Inc has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report