Device recall
Z-1270-2016: Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is…
FDA device recall · Class II · Laserex Systems Inc.
Key facts
| Recall number (Z-number) | Z-1270-2016 |
|---|---|
| Recall event | 73468 |
| Product | Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. . |
| Product code | HQF |
| Recalling firm | Laserex Systems Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 27, 2016 |
| 510(k) numbers | K052777 |
| FEI number | 3002806902 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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