Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MC-500 Multicolor Laser Photocoagulator Recalled by Nidek Inc Due to The spot size control of the scan delivery...
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; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
Quantity: 16 units in commerce
Why Was This Recalled?
The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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