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.
This recall has been terminated (originally issued April 1, 2020).
- Company
- Ra Medical Systems, Inc.
- Recall Initiated
- August 23, 2019
- Posted
- April 1, 2020
- Terminated
- May 5, 2021
- Recall Number
- Z-1631-2020
- Quantity
- 10
- Firm Location
- Carlsbad, CA
- Official Source
- View on FDA website ↗
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
U.S. Nationwide distribution in the states of CA, FL, OR, MS, NY.
Lot / Code Info
All serial numbers.
Root Cause
Software change control
Action Taken
On 08/23/2019, Medical Device Correction was mailed to customers. Customers were informed that the recalling firm's service department would contact them to replace the software. Unitl the software is replaced, do not use doses less than 100 mJ. During service visits customers were informed that software was updated to 1.06 ZRPL