Device recall
Z-1843-2021: Quanta System Sterile Optical Laser Fiber, single use
FDA device recall · Class II · Quanta System, S.p.A.
Key facts
| Recall number (Z-number) | Z-1843-2021 |
|---|---|
| Recall event | 87814 |
| Product | Quanta System Sterile Optical Laser Fiber, single use |
| Product code | GEX |
| Recalling firm | Quanta System, S.p.A. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 5, 2023 |
| 510(k) numbers | K131473 |
| FEI number | 3004378299 |
At a glance
- 1–9 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