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.
This recall has been terminated (originally issued October 16, 2020).
- Company
- Ra Medical Systems, Inc.
- Recall Initiated
- October 16, 2020
- Terminated
- January 11, 2023
- Recall Number
- Z-0569-2021
- Quantity
- 36 devices
- Firm Location
- Carlsbad, CA
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
On 10/29/2020, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification via certified mail informing them of the potential for the footswitch to fail to operate properly if liquid is spilled near or on the footswitch. On 11/16/2020, the firm sent out an updated customer notification. The firm is instructing customers to discontinue using the footswitch if liquids have been spilled on or splashed on the floor near or on the footswitch. The Recalling Firm will ship a replacement footswitch and will provide shipping materials for users to return the old footswitch. Instructions will be provided on how to install the new footswitch and return the old footswitch. Customers are asked to fill out and return the Acknowledgement and Receipt Form via FAX to 760-867-2706 or email at fieldcorrectiveaction@ramed.com. For any questions, contact the Recalling Firm at: 1-877-635-1800 Monday thru Friday 8:00 a.m. to 5:00 p.m. PST