Recall archive / FDA device enforcement
X80 RADiant Photoelectric Therapy System — FDA record Z-1404-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 27, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- X80 RADiant Photoelectric Therapy System
- Reason
- There is a potential compatibility issue with the systems and replacement treatment applicators.
- Classification
- Class II
- Recalling firm
- Xstrahl Limited
- Quantity
- 7 devices; 70 treatment applicators
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1404-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution FL, CA, KY
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 27, 2022
- Recall initiation date
- Apr 27, 2022
- Center classification date
- Jul 19, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.