Reported Mar 29, 2017 · Terminated
Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System.…
Nidek Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nidek Inc · 47651 Westinghouse Dr · Fremont, CA · 94539-7474
Is this the product you have?
- Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of 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.
- Lot codes and dates
29 of 29 products
Products covered by this recall # Product as published 1 MNE0009 2 NVE0002 3 OH00295 4 NC00185 5 CAE0016 6 COE0008 7 MI00131 8 GA00241 9 CAE0007 10 VAE0004 11 MI00131 12 CAE0031 13 AZ00167 14 COE0011 15 CA00561 16 PAE0003 17 TN00168 18 MNE0009 19 WA00246 20 CAE0047 - Amount recalled
- 29
Where it was sold
Why it was recalled
During treatment planning, the procedure was programmed with an unintended (wrong) correction.
This product could cause temporary or reversible health problems — stop using it.
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