medical Class II Updated 2020-10-14

Ra Medical Systems, Inc. recalls DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The

Recalled Product

DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.


Hazard / Issue

Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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.
View official government recall

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