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 software is programmed onto an EEPROM chip, which is a component of the DABRA Excimer Laser RA-308 s Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 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 s
Brand
Ra Medical Systems, Inc.
Lot Codes / Batch Numbers
Serial Number(s): RA00027 through RA00176, all DABRA excimer laser RA-308 product is impacted.
Products Sold
Serial Number(s): RA00027 through RA00176;all DABRA excimer laser RA-308 product is impacted.
Ra Medical Systems, Inc. is recalling DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviol due to A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an uninte. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, NV, NY, NC, OK, OR, PA, TN, TX, WI
Page updated: Jan 10, 2026