Ra Medical Systems, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2497-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 23, 2020

Date Posted: July 15, 2020

Recall Number: Z-2497-2020

Event ID: 85790

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.

Status: Terminated

Product Quantity: 79 units

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated