Home / Recalls / Ra Medical Systems, Inc. / Z-0569-2021

Z-0569-2021 Class II Terminated

Recalled by Ra Medical Systems, Inc. — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
December 23, 2020
Initiation Date
October 16, 2020
Termination Date
January 11, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36 devices

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.

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.

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.

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.

Other recalls by Ra Medical Systems, Inc.

  • Z-0050-2021 Class II — DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended (July 24, 2020)
  • Z-2497-2020 Class II — DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an exc (January 23, 2020)
  • Z-2006-2020 Class II — Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400- (September 19, 2019)
  • Z-1631-2020 Class II — Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer L (August 23, 2019)
  • Z-2218-2019 Class II — The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy e (February 15, 2018)
  • Z-2123-2014 Class II — PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of (June 30, 2014)