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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.

FDA Recall Z-0223-2015 · Posted 2014-11-17

Recalling FirmNidek Inc
Recall StatusTerminated
Product CodeLZS
Date Initiated2012-08-06
Date Terminated2014-11-17
Product Quantity14 units

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.

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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