Ra Medical Systems, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0569-2021)

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 Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.

Product Classification:

Class II

Date Initiated: October 16, 2020

Date Posted: December 23, 2020

Recall Number: Z-0569-2021

Event ID: 86692

Reason for Recall:

Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase.

Status: Terminated

Product Quantity: 36 devices

Code Information:

Model Number RA-308 Product/Catalog Number: 1200-0001-01 Serial Numbers: RA00027, RA00046, RA00049, RA00050, RA00054, RA00056, RA00057, RA00058, RA00064, RA00069, RA00073, RA00081, RA00083, RA00084, RA00085, RA00089, RA00097, RA00098, RA00114, RA00115, RA00120, RA00121, RA00125, RA00127, RA00135, RA00138, RA00148, RA00153, RA00154, RA00160, RA00164, RA00165, RA00167, RA00170, RA00175, and RA00177.

Distribution Pattern:

US Distribution to states of: AL, AZ, CA, FL, IL, IN, KY, LA, MD, NC, NV, NY, OK, OR, TX, and WA; and to OUS country: Japan.

Voluntary or Mandated:

Voluntary: Firm initiated