Device recall
Z-1245-2016: RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument…
FDA device recall · Class II · Nidek Inc
Key facts
| Recall number (Z-number) | Z-1245-2016 |
|---|---|
| Recall event | 73316 |
| Product | RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions. |
| Product code | HKN |
| Recalling firm | Nidek Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 24, 2018 |
| FEI number | 2936921 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database