Drug recall
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For…
FDA recall event 68766 · Class II · Nidek Inc
Key facts
| Event ID | 68766 |
|---|---|
| Recall numbers | Z-2132-2014 |
| Recalling firm | Nidek Inc |
| Product type | Devices |
| Products | MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Laser aperture label was not affixed to device prior to shipment in the US. |
| Initiation date | Jun 9, 2014 |
| Report date | Aug 6, 2014 |
| Termination date | Nov 24, 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: