FDAFDA · Food and drugs·Recall number Z-0223-2015
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.
Published November 26, 2014 · Recall initiated: August 6, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Nidek Inc
- Distributor
- US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.
- Lot
- Serial numbers: 530054 530055 530070 530073 530078 530082 530086 530087 530098 530106 530121 530123 530150 530155
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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