Device recall
Z-2587-2016: OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The…
FDA device recall · Class II · Nidek Inc
Key facts
| Recall number (Z-number) | Z-2587-2016 |
|---|---|
| Recall event | 74595 |
| Product | OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior… |
| Product code | HJO |
| Recalling firm | Nidek Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 22, 2016 |
| 510(k) numbers | K133132 |
| FEI number | 2936921 |
At a glance
- 1–9 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