Device recall
Z-2405-2016: Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system…
FDA device recall · Class II · Topcon Medical Laser Systems, Inc
Key facts
| Recall number (Z-number) | Z-2405-2016 |
|---|---|
| Recall event | 74724 |
| Product | Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally. |
| Product code | HQF |
| Recalling firm | Topcon Medical Laser Systems, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 29, 2019 |
| 510(k) numbers | K123542 |
| FEI number | 2939653 |
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