Ra Medical Systems, Inc. recalls Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the sk…

Recall date

August 23, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1631-2020

FDA classification

Class II

Brand / firm

Ra Medical Systems, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.