Ra Medical Systems, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0050-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 24, 2020

Date Posted: October 14, 2020

Recall Number: Z-0050-2021

Event ID: 86217

Reason for Recall:

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

Status: Terminated

Product Quantity: 54 units

Code Information:

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.

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, ID, IL, IN, KS, KY, LA, MA, MD, MI, NC, NV, NY, OR, OK, PA, TX, WA and the country of Japan.

Voluntary or Mandated:

Voluntary: Firm initiated