Home / Recalls / Ra Medical Systems, Inc. / Z-2497-2020

Z-2497-2020 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
July 15, 2020
Initiation Date
January 23, 2020
Termination Date
November 1, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
79 units

Product Description

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.

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.

Distribution Pattern

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.

Code Information

Serial Number(s): RA00027 through RA00176;all DABRA excimer laser RA-308 product is impacted.

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-0050-2021 Class II — DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended (July 24, 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)