Xstrahl recalls X80 RADiant Photoelectric Therapy Systems with specific lot codes due to potential compatibility issues with replacement treatment applicators. Affected units may not function properly with new applicators.
There is a potential compatibility issue with the systems and replacement treatment applicators.
Xstrahl is recalling X80 RADiant Photoelectric Therapy Systems with certain lot codes because they might not work properly with replacement treatment applicators. This could lead to treatment failures if the system and applicator aren't compatible.
The system may not function correctly with replacement treatment applicators due to a compatibility issue. This could cause treatment failures if the system and applic:ators are not properly matched.
Users of the X80 RADiant Photoelectric Therapy System with lot codes GM0549 through GM0577 are affected. Patients receiving physical therapy treatments are most at risk of treatment failure.
Check the lot codes on your X80 RADiant Photoelectric Therapy System: GM0549, GM0567, GM0568, GM0569, GM0570, GM0571, and GM0577. The product may also have a UDI/DI code starting with 5060494200008.
Look for lot codes GM0549, GM0567, GM0568, GM0569, GM0570, GM0571, or GM0577 on your X80 RADiant Photoelectric Therapy System.
No, the recall does not require immediate discontinuation. The issue is about compatibility with replacement applicators, not a safety hazard.
Check the lot codes on your system. If it matches the listed codes, contact Xstrahl for guidance on compatible applicators.
The recall does not specify a fix. Affected users should contact Xstrahl to ensure they have compatible treatment applicators.
We’ve drafted a message you can send Xstrahl to request your refund or repair — edit it as you like.
Subject: Recall Z-1404-2022 — Xstrahl Xstrahl Hello, I own a Xstrahl that is covered by recall Z-1404-2022 from Xstrahl. 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.
