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U.S. Department of Health and Human Services

Class 2 Device Recall DABRA RA308 Excimer Laser

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 Class 2 Device Recall DABRA RA308 Excimer Lasersee related information
Date Initiated by FirmJuly 24, 2020
Create DateOctober 02, 2020
Recall Status1 Terminated 3 on August 09, 2023
Recall NumberZ-0050-2021
Recall Event ID 86217
510(K)NumberK170349 
Product Classification Catheter for crossing total occlusions - Product Code PDU
ProductDABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
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.
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 the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
FDA Determined
Cause 2		Device Design
ActionOn August 10, 2020, the firm sent an "Urgent Medical Correction" letter to customers, informing them of the incorrect laser wheel size, which upon moving or adjusting the laser with the wheels in locked position may fall over. If this were to happen during a medical procedure, user or patient injury may occur.
Quantity in Commerce54 units
DistributionWorldwide 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.
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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