Recall Z-0223-2015— Nidek Inc
Class II · Terminated
Class II FDA medical device recall by Nidek Inc, initiated 2012-08-06, terminated 2014-11-17. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Nidek Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-06
- Terminated
- 2014-11-17
- Firm location
- Fremont, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.