Drug recall
Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a…
FDA recall event 69508 · Class II · Nidek Inc
Key facts
| Event ID | 69508 |
|---|---|
| Recall numbers | Z-0223-2015 |
| Recalling firm | Nidek Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Aug 6, 2012 |
| Report date | Nov 26, 2014 |
| Termination date | Nov 17, 2014 |
| City | Fremont |
| State | CA |
| Country | United States |
| FEI number | 2936921 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: