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U.S. Department of Health and Human Services

Class 2 Device Recall DABRA Excimer Laser RA308

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 Class 2 Device Recall DABRA Excimer Laser RA308see related information
Date Initiated by FirmOctober 16, 2020
Create DateDecember 14, 2020
Recall Status1 Terminated 3 on January 11, 2023
Recall NumberZ-0569-2021
Recall Event ID 86692
510(K)NumberK170349 
Product Classification Catheter for crossing total occlusions - Product Code PDU
ProductDABRA 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.
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.
FEI Number 3004217728
Recalling Firm/
Manufacturer		 Ra Medical Systems, Inc.
2070 Las Palmas Dr
Carlsbad CA 92011-1518
For Additional Information ContactWill McGuire
760-804-1648
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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
Quantity in Commerce36 devices
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = PDU
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