Pharos Excimer Laser, Model: EX-308 - Product Usage: The… recallZ-1631-2020 · Ra Medical Systems, Inc. · initiated Aug 23, 2019
Class II Terminated All recalls posted in April 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ra Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Software change control
What the company is doing
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
Recall details
- Recall number
- Z-1631-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 23, 2019
- Posted by the FDA
- Apr 1, 2020
- Recalling firm
- Ra Medical Systems, Inc.
- Quantity
- 10
- Product code
- GEX
- FDA submissions
- K062963
- Distribution
- U.S. Nationwide distribution in the states of CA, FL, OR, MS, NY.
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.
Code information (models, lots, serial numbers)
All serial numbers.
Other devices under the same FDA submission
1 device cleared under K062963 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Pharos EX-308Catheter Precision, Inc. · Powered Laser Surgical Instrument3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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