Drug recall
NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification…
FDA recall event 84112 · Class III · Nidek, Inc.
Key facts
| Event ID | 84112 |
|---|---|
| Recall numbers | Z-0771-2020 |
| Recalling firm | Nidek, Inc. |
| Product type | Devices |
| Products | NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2) |
| Initiation date | Feb 25, 2019 |
| Report date | Jan 8, 2020 |
| Termination date | Jun 15, 2021 |
| 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: