Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall RA308 Excimer Laser System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall RA308 Excimer Laser System see related information
Date Initiated by Firm January 23, 2020
Date Posted July 04, 2020
Recall Status1 Terminated 3 on November 01, 2021
Recall Number Z-2497-2020
Recall Event ID 85790
510(K)Number K170349  
Product Classification Catheter for crossing total occlusions - Product Code PDU
Product DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The optical conduit is used in conjunction with existing endovascular accessories and tools to complete a surgical procedure. The software is programmed onto an EEPROM chip, which is a component of the DABRA Excimer Laser RA-308 system. Catheter for crossing total occlusions in vascular system.
Code Information Serial Number(s): RA00027 through RA00176;all DABRA excimer laser RA-308 product is impacted.
Recalling Firm/
Manufacturer		 Ra Medical Systems, Inc.
2070 Las Palmas Dr
Carlsbad CA 92011-1518
For Additional Information Contact Mr. Will McGuire
760-804-1648
Manufacturer Reason
for Recall		 A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.
FDA Determined
Cause 2		 Software design
Action The Urgent Medical Device Correction notification was sent as certified mail USPS letter to consignees on 1/31/2020. The requested actions are as follows: 1. Do not use the excimer laser until a service technician has installed the new version of software to correct the issue. 2. Complete and return the acknowledgement form, whether you have any of the affected product or not, indicating: * Whether you have the excimer laser in question at your facility, *If you do have the excimer laser, the physical address where the product is located; and, *The person to be contacted to schedule a service call to correct the issue. Should you have any questions or need further assistance call (442) 325-5044.
Quantity in Commerce 79 units
Distribution US: AL, AZ, CA, FL, GA, ID, IL, IN, KS, KY, LA, MI, MD, NC, NV, NY, OK, OR, PA, TN,TX, WI. OUS: Italy and Japan.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = PDU and Original Applicant = Ra Medical Systems, Inc.
-
-