Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Recalled by Nidek Inc Due to When the MC-500 is turned on and coagulation...
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
Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.
Quantity: 21affected devices
Why Was This Recalled?
When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program.
Where Was This Sold?
This product was distributed to 11 states: CA, IL, IN, MI, MN, NJ, NY, OH, SC, TX, UT
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