Device recall
Z-0569-2021: DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel…
FDA device recall · Class II · Ra Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0569-2021 |
|---|---|
| Recall event | 86692 |
| Product | DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease. |
| Product code | PDU |
| Recalling firm | Ra Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 11, 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