Home / Recalls / Ra Medical Systems, Inc. / Z-0050-2021

Z-0050-2021 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
October 14, 2020
Initiation Date
July 24, 2020
Termination Date
August 9, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
54 units

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.

Reason for Recall

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

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.

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.

Other recalls by Ra Medical Systems, Inc.

  • Z-0569-2021 Class II — DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channe (October 16, 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)