# FDA recall Z-2497-2020

> **Ra Medical Systems, Inc.** · Class II · device recall initiated 2020-01-23.

## 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.

## 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

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.

## Key facts

- **Recall number:** Z-2497-2020
- **Recalling firm:** Ra Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-23
- **Report date:** 2020-07-15
- **Termination date:** 2021-11-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2497-2020

## Citation

> AI Analytics. FDA recall Z-2497-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2497-2020. Source: US FDA. Licensed CC0.

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