Ra Medical Systems, Inc. DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
Brand
Ra Medical Systems, Inc.
Lot Codes / Batch Numbers
Model Number DABRA Excimer Laser RA-308, Serial Numbers: RA00027, RA00039, RA00046, RA00049, RA00050, RA00054, RA00055, RA00056, RA00057, RA00058, RA00063, RA00064, RA00065, RA00067, RA00069, RA00070, RA00073, RA00074, RA00081, RA00082, RA00083, RA00084, RA00085, RA00086, RA00088, RA00089, RA00097, RA00098, RA00103, RA00114, RA00115, RA00117, RA00118, RA00120, RA00121, RA00124, RA00125, RA00127, RA00135, RA00136, RA00137, RA00138, RA00143, RA00147, RA00148, RA00153, RA00154, RA00160, RA00164, RA00165, RA00167, RA00170, RA00175, and RA00177.
Products Sold
Model Number DABRA Excimer Laser RA-308; Serial Numbers: RA00027, RA00039, RA00046, RA00049, RA00050, RA00054, RA00055, RA00056, RA00057, RA00058, RA00063, RA00064, RA00065, RA00067, RA00069, RA00070, RA00073, RA00074, RA00081, RA00082, RA00083, RA00084, RA00085, RA00086, RA00088, RA00089, RA00097, RA00098, RA00103, RA00114, RA00115, RA00117, RA00118, RA00120, RA00121, RA00124, RA00125, RA00127, RA00135, RA00136, RA00137, RA00138, RA00143, RA00147, RA00148, RA00153, RA00154, RA00160, RA00164, RA00165, RA00167, RA00170, RA00175, and RA00177.
Ra Medical Systems, Inc. is recalling DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating due to Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
Recommended Action
Per FDA guidance
On August 10, 2020, the firm sent an "Urgent Medical Correction" letter to customers, informing them of the incorrect laser wheel size, which upon moving or adjusting the laser with the wheels in locked position may fall over. If this were to happen during a medical procedure, user or patient injury may occur.
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 noticePage updated: Jan 10, 2026