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.
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.
The laser system has a software error that prevents it from stopping when the foot pedal or switch is released. This can cause the laser to continue firing at high doses, leading to over-treatment. Over-treatment may result in skin redness or blisters.
Medical professionals using the EX-308 laser for skin treatments are most at risk. Patients receiving these treatments could experience skin irritation or blisters if the device malfunctions.
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.
Verify if the laser is operating in custom or auto repeat modes, as these modes may be affected by the software error.
Reach out to Ra Medical Systems for guidance on whether the device needs repair or adjustment.
The EX-308 laser treats skin disorders such as psoriasis, vitiligo, atopic dermatitis, and leukoderma.
The recall states that the error may cause strong erythema (redness) and possibly blisters, but does not mention serious injury.
All EX-308 laser systems have serial numbers. Check if your device is used in custom or auto repeat modes.
We’ve drafted a message you can send Ra Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1631-2020 — Ra Medical Systems Ra Medical Systems Hello, I own a Ra Medical Systems that is covered by recall Z-1631-2020 from Ra Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
