Xstrahl X80 RADiant Therapy System Recall: Compatibility Issues with Applicators
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.
Lower-risk recall
There is a potential compatibility issue with the systems and replacement treatment applicators.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/60758-xstrahl-x80-radiant-therapy-system-recall-compatibility-issues-with-applicators.
Source Summary by GovInfoNow · govinfonow.com/recall/60758-xstrahl-x80-radiant-therapy-system-recall-compatibility-issues-with-applicators · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1404-2022
Cite this page
“Xstrahl X80 RADiant Therapy System Recall: Compatibility Issues with Applicators.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/60758-xstrahl-x80-radiant-therapy-system-recall-compatibility-issues-with-applicators. Based on FDA recall #Z-1404-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1404-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Xstrahl- Category
Medical device
What to do — step by step
Check Lot Codes
Look for lot codes GM0549, GM0567, GM0568, GM0569, GM0570, GM0571, or GM0577 on your X80 RADiant Photoelectric Therapy System.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “US Distribution FL, CA, KY” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Kentucky.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the system immediately?
No, the recall does not require immediate discontinuation. The issue is about compatibility with replacement applicators, not a safety hazard.
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Where this comes from
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-1404-2022 (April 27, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1404-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.