FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0223-2015
- Recalling firm
- Nidek Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2012-08-06
- Posted
- 2014-11-17
- Terminated
- 2014-11-17
- 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.
- Lot, serial or model codes
- Serial numbers: 530054 530055 530070 530073 530078 530082 530086 530087 530098 530106 530121 530123 530150 530155
- 510(k) numbers
- not on file
- PMA numbers
- ["P970053"]
- Product code
- LZS
- Firm FEI
- 2936921
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28