# FDA recall Z-0050-2021

> **Ra Medical Systems, Inc.** · Class II · device recall initiated 2020-07-24.

## Product

DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.

## Reason for recall

Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, ID, IL, IN, KS, KY, LA, MA, MD, MI, NC, NV, NY, OR, OK, PA, TX, WA and the country of Japan.

## Key facts

- **Recall number:** Z-0050-2021
- **Recalling firm:** Ra Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-24
- **Report date:** 2020-10-14
- **Termination date:** 2023-08-09

- **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-0050-2021

## Citation

> AI Analytics. FDA recall Z-0050-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0050-2021. Source: US FDA. Licensed CC0.

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