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.
This recall has been terminated (originally issued November 17, 2014).
- Company
- Nidek Inc
- Recall Initiated
- August 6, 2012
- Posted
- November 17, 2014
- Terminated
- November 17, 2014
- Recall Number
- Z-0223-2015
- Quantity
- 14 units
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
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.
Distribution
US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.
Lot / Code Info
Serial numbers: 530054 530055 530070 530073 530078 530082 530086 530087 530098 530106 530121 530123 530150 530155
Root Cause
Component design/selection
Action Taken
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.