Recall Z-2497-2020 ยท PDU Catheter For Crossing Total Occlusions
Ra Medical Systems, Inc.
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 conjunction with existing endovascular accessories and tools to complete a surgical procedure. The
| Date | Jul 4, 2020 (initiated Jan 23, 2020) |
| Status | Terminated |
| Reason | A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient. |
| Root cause | Software design |
| Action | The Urgent Medical Device Correction notification was sent as certified mail USPS letter to consignees on 1/31/2020. The requested actions are as follows: 1. Do not use the excimer laser until a service technician has installed the new version of software to correct the issue. 2. Complete and return the acknowledgement form, whether you have any of the affected product or not, indicating: * Whether you have the excimer laser in question at your facility, *If you do have the excimer laser, the physical address where the product is located; and, *The person to be contacted to schedule a service |
| Quantity | 79 units |
| Distribution | US: AL, AZ, CA, FL, GA, ID, IL, IN, KS, KY, LA, MI, MD, NC, NV, NY, OK, OR, PA, TN,TX, WI. OUS: Italy and Japan. |
| 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 |