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 software is programmed onto an EEPROM chip, which is a component of the DABRA Excimer Laser RA-308 system. Catheter for crossing total occlusions in vascular system.

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.

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 call to correct the issue. Should you have any questions or need further assistance call (442) 325-5044.