Nidek Inc: Medical Device Recall in 2014 - (Recall #: Z-0223-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 6, 2012

Date Posted: November 26, 2014

Recall Number: Z-0223-2015

Event ID: 69508

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.

Status: Terminated

Product Quantity: 14 units

Code Information:

Serial numbers: 530054 530055 530070 530073 530078 530082 530086 530087 530098 530106 530121 530123 530150 530155

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated