Reported Apr 8, 2020 · Terminated
Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the…
Ra Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ra Medical Systems, Inc. · 2070 Las Palmas Dr · Carlsbad, CA · 92011-1518
Is this the product you have?
- Pharos Excimer Laser
- ModelEX-308 -
- Product UsageThe 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
- Lot codes and dates
- All serial numbers.
- Amount recalled
- 10
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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