FDA Device recall Z-0223-2015
Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device
- FDA Device
- Class II
- terminated
- Published 2014-11-26
On 2014-11-26 the FDA classified a Class II recall of Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device by Nidek, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0223-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-06 |
| Published | 2014-11-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nidek |
| Distribution | AZ, CA, CO, CT, FL, LA, ME, MI, MO, NY |
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.
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.
Identifiers
| code_info | Serial numbers: 530054 530055 530070 530073 530078 530082 530086 530087 530098 530106 530121 530123 530150 530155 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0223-2015%22
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