Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in Recalled by Ra Medical Systems, Inc. Due to Due to footswitch not meeting required specification for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ra Medical Systems, Inc. directly.
Affected Products
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.
Quantity: 36 devices
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 16 states: AL, AZ, CA, FL, IL, IN, KY, LA, MD, NV, NY, NC, OK, OR, TX, WA
About Ra Medical Systems, Inc.
Ra Medical Systems, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report