Recall Z-0223-2015 ยท LZS Excimer Laser System
Nidek Inc
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.
| Date | Nov 17, 2014 (initiated Aug 6, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 14 units |
| Distribution | US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.