Recall Z-1494-2017— Nidek Inc
Class II · Terminated
Class II FDA medical device recall by Nidek Inc, initiated 2017-02-01, terminated 2017-12-05. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: During treatment planning, the procedure was programmed with an unintended (wrong) correction..
- Recalling firm
- Nidek Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-01
- Terminated
- 2017-12-05
- Firm location
- Fremont, CA, United States
Product description
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.
Reason for recall
During treatment planning, the procedure was programmed with an unintended (wrong) correction.
Data sourced from openFDA. This site is unofficial and independent of the FDA.