# FDA recall Z-0569-2021

> **Ra Medical Systems, Inc.** · Class II · device recall initiated 2020-10-16.

## Product

DABRA Laser (RA-308 Excimer Laser)    Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.

## Reason for recall

Due to footswitch not meeting required specification for protection from ingress of solids or liquids.  If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase.

## Distribution

US Distribution to states of: AL, AZ, CA, FL, IL, IN, KY, LA, MD, NC, NV, NY, OK, OR, TX, and WA; and to OUS country: Japan.

## Key facts

- **Recall number:** Z-0569-2021
- **Recalling firm:** Ra Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-16
- **Report date:** 2020-12-23
- **Termination date:** 2023-01-11

- **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-0569-2021

## Citation

> AI Analytics. FDA recall Z-0569-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0569-2021. Source: US FDA. Licensed CC0.

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