Ra Medical Systems, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1631-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 23, 2019

Date Posted: April 8, 2020

Recall Number: Z-1631-2020

Event ID: 85200

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.

Status: Terminated

Product Quantity: 10

Code Information:

All serial numbers.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated