# FDA recall Z-1631-2020

> **Ra Medical Systems, Inc.** · Class II · device recall initiated 2019-08-23.

## Product

Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The excimer laser system produces collimated 308 nm radiation, within the invisible region of the electromagnetic spectrum. The UV radiation falls within the range of ultraviolet B (UVB), which is used to treat photo-responsive skin disorders.

## Reason for recall

At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer laser phototherapy system causes the device to fail to cease firing as long as the foot pedal or handpiece switch is depressed. This malfunction can cause overtreatment, which could result in strong erythema, and possibly cause blisters.

## Distribution

U.S. Nationwide distribution in the states of CA, FL, OR, MS, NY.

## Key facts

- **Recall number:** Z-1631-2020
- **Recalling firm:** Ra Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-23
- **Report date:** 2020-04-08
- **Termination date:** 2021-05-05

- **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-1631-2020

## Citation

> AI Analytics. FDA recall Z-1631-2020. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-1631-2020. Source: US FDA. Licensed CC0.

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