Recall Z-2218-2019 ยท PDU Catheter For Crossing Total Occlusions
Ra Medical Systems Inc
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 a microprocessor with software to provide safety features and a user-friendly interface. The laser
| Date | Feb 15, 2018 |
| Status | Terminated |
| Reason | Lasers/Catheters did not calibrate during set-up prior to use. |
| Root cause | Other |
| Action | On 02/15/18, service technicians started visiting customer facilities to service affected lasers. |
| Quantity | 4 |
| Distribution | U.S: CA, PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170349 | RA-308 Excimer Laser System, Excimer Laser Catheter Ra Medical Systems,Inc, May 24, 2017 |