Pharos Excimer Laser — Class II medical device recall Z-1631-2020

Terminated recall by Ra Medical Systems, Inc., reported 2020-04-08, distributed nationwide. At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer laser photother

Recall number	`Z-1631-2020`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Ra Medical Systems, Inc., Carlsbad, CA, United States
Recall initiated	2019-08-23
Classified	2020-04-01
Reported by FDA	2020-04-08
Terminated	2021-05-05
Distributed	Nationwide (US)
Quantity	10
Reason classes	device malfunction, software
Model numbers	`EX-308`

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1631-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.