FDA Enforcement
Class II
Terminated
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.
Recall: Z-0223-2015
·
Reported November 26, 2014
Enforcement
- Recall Number
- Z-0223-2015
- Event ID
- 69508
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Nidek Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- November 26, 2014
- Initiation Date
- August 6, 2012
- Classification Date
- November 17, 2014
- Termination Date
- November 17, 2014
- Address
- 47651 Westinghouse Dr, N/A, Fremont, CA, 94539-7474, United States
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
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.
Code Info
Serial numbers: 530054 530055 530070 530073 530078 530082 530086 530087 530098 530106 530121 530123 530150 530155
Distribution
US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.
Quantity
14 units