Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nidek Excimer Laser Corneal Surgery System Recalled by Nidek Inc Due to Contact failure in F1 and F4 fuse holders...
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 Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
Quantity: 14 units
Why Was This Recalled?
Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the patient.
Where Was This Sold?
This product was distributed to 10 states: AZ, CA, CO, CT, FL, LA, ME, MI, MO, 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