Device recall
Z-2497-2020: DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an…
FDA device recall · Class II · Ra Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2497-2020 |
|---|---|
| Recall event | 85790 |
| Product | DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The optical conduit is used in… |
| Product code | PDU |
| Recalling firm | Ra Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 1, 2021 |
| 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