08

Apr

2020

Recall – Phototherapy system fails to shut off laser under certain conditions

recall, softwareerror

0

Company: Ra Medical Systems, Inc.
Date of Enforcement Report: 4/8/2020
Class II

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.

Recall Number: Z-1631-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

Ra Medical Systems, Inc. on 8/23/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

10

DISTRIBUTION

US Nationwide

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