Home / Recalls / Medical Devices
Ra Medical Systems, Inc. recalls DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disea
Recalled December 23, 2020 · FDA recall Z-0569-2021 · Ra Medical Systems
Hazard
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. · FDA Class II
Units
36 devices
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Ra Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →