Use cautionMedical device recall · FDA · Published August 23, 2019
Ra Medical Systems EX-308 Laser Recall: Software Error Causes Overtreatment Risk
Ra Medical Systems recalls EX-30:8 excimer laser systems due to software error causing over-treatment risks. Affected units may cause skin blisters or strong redness. Contact for remedy.
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.
Take action
Contact the company
📍Recalling firmRa Medical Systems, Inc.2070 Las Palmas Dr · Carlsbad, CA 92011-1518
✎ GovInfoNow plain-language explainer
Ra Medical Systems is recalling their EX-308 excimer laser systems because a software error can cause the device to keep firing even when the user releases the foot pedal or switch. This may lead to over-treatment, causing skin redness or blisters. The recall affects medical devices used for treating skin conditions like psoriasis and vitiligo. Read more at govinfonow.com/recall/67108-ra-medical-systems-ex-308-laser-recall-software-error-causes.
“Ra Medical Systems EX-308 Laser Recall: Software Error Causes Overtreatment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67108-ra-medical-systems-ex-308-laser-recall-software-error-causes. Based on FDA recall #Z-1631-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1631-2020%22&limit=1).
Ra Medical Systems, Inc. recalled Pharos Excimer Laser Model EX-308 units nationwide on August 23, 2019, according to the FDA. A software error can cause the device to fail to cease firing, potentially resulting in strong erythema or blisters.
How to tell if you have it
Brand: Ra Medical Systems
Product: Pharos Excimer Laser
Model: EX-308
Serial numbers: All serial numbers
The hazard
At doses of less than 100 mJ, 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.
Context
GovInfoNow's records show Ra Medical Systems, Inc. has had five other recalls on record since February 15, 2018. Other recent recalls of similar products include Diowave Laser System Recall (January 9, 2026), Lutronic DermaV Laser System Recall (August 6, 2026), and Lutronic CLARITY II Laser System Model 1110200210 Sparks and May Burn Patients (January 27, 2026).
How to tell if you have this one
The EX-308 excimer laser system is used for treating skin disorders like psoriasis and vitiligo. All units have serial numbers. The product was sold for medical use.
Brand
Ra Medical Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Settings
Verify if the laser is operating in custom or auto repeat modes, as these modes may be affected by the software error.
Contact Manufacturer
Reach out to Ra Medical Systems for guidance on whether the device needs repair or adjustment.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of CA, FL, OR, MS, NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Mississippi, New York, Oregon.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1631-2020 (August 23, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1631-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.