The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1631-2020·Announced 2020-04-08

Ra Medical Systems Recalls Pharos Excimer Laser Due to Software Error

Ra Medical Systems is recalling 10 Pharos EX-308 Excimer Laser units because a software error may prevent the device from stopping, potentially causing skin burns.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where injury (blisters, erythema) has not yet been reported, fitting the 'High' severity criteria for theoretical or unreported harm.

Plain-English summary

Ra Medical Systems, Inc. is recalling 10 units of the Pharos EX-308 Excimer Laser System. The device is used to treat skin disorders such as psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The recall is due to a software error that occurs at doses of less than 100 mJ in custom and auto repeat modes.

The software error causes the device to fail to cease firing as long as the foot pedal or handpiece switch is depressed. This malfunction can result in overtreatment, which could cause strong erythema (redness) and possibly blisters. The affected units were distributed nationwide in California, Florida, Oregon, Mississippi, and New York.

Healthcare providers and consumers should stop using the affected devices immediately. Ra Medical Systems, Inc. is the recalling firm and is responsible for addressing the defect. No specific serial numbers are listed, indicating all serial numbers for the recalled units are affected.

The recalled product

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…
Manufacturer
Ra Medical Systems, Inc.
Category
Medical Device — Laser Therapy
Hazard
Affected units
10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers.

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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