U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Excimer laser system - Product Code LZS
원인
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.
조치
Nidek Engineers visited each site to perform correction - fuse holders have been inspected and replaced if necessary.
An Engineering Change Order was issued on June 1, 2012, for inspection and/or replacement of affected fuse holders by Nidek Service Engineers.
For further questions please call (510) 353-7785.
US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.
제품 설명
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.