Home / Recalls / Ra Medical Systems, Inc. / Z-1631-2020

Z-1631-2020 Class II Terminated

Recalled by Ra Medical Systems, Inc. — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
April 8, 2020
Initiation Date
August 23, 2019
Termination Date
May 5, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10

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.

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 Pattern

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

Code Information

All serial numbers.

Other recalls by Ra Medical Systems, Inc.

  • Z-0569-2021 Class II — DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channe (October 16, 2020)
  • Z-0050-2021 Class II — DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended (July 24, 2020)
  • Z-2497-2020 Class II — DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an exc (January 23, 2020)
  • Z-2006-2020 Class II — Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400- (September 19, 2019)
  • Z-2218-2019 Class II — The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy e (February 15, 2018)
  • Z-2123-2014 Class II — PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of (June 30, 2014)