Device recall
Z-0050-2021: DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended…
FDA device recall · Class II · Ra Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0050-2021 |
|---|---|
| Recall event | 86217 |
| Product | DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease. |
| Product code | PDU |
| Recalling firm | Ra Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 9, 2023 |
| 510(k) numbers | K170349 |
| FEI number | 3004217728 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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