Z-0223-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 26, 2014
- Initiation Date
- August 6, 2012
- Termination Date
- November 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
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.
Distribution Pattern
US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.
Code Information
Serial numbers: 530054 530055 530070 530073 530078 530082 530086 530087 530098 530106 530121 530123 530150 530155