Device recall
Z-2172-2017: Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device…
FDA device recall · Class II · Laserex Systems Inc.
Key facts
| Recall number (Z-number) | Z-2172-2017 |
|---|---|
| Recall event | 77170 |
| Product | Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures requiring the rupture of… |
| Product code | GEX |
| Recalling firm | Laserex Systems Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 31, 2017 |
| FEI number | 1000520094 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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