Device recall
Z-2218-2019: The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy…
FDA device recall · Class II · Ra Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-2218-2019 |
|---|---|
| Recall event | 83348 |
| Product | The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The light source contains… |
| Product code | PDU |
| Recalling firm | Ra Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| 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