Device recall
Z-2501-2018: Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number…
FDA device recall · Class II · Medtronic Navigation, Inc.
Key facts
| Recall number (Z-number) | Z-2501-2018 |
|---|---|
| Recall event | 80481 |
| Product | Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560 Visualase Cooled Laser Applicator System 10mm Tip; c. Part Number 9735561 Visualase Cooled Laser Applicator System 15mm Tip Product Usage: The… |
| Product code | GEX |
| Recalling firm | Medtronic Navigation, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 31, 2023 |
| 510(k) numbers | K053087 |
| FEI number | 1000517638 |
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