X80 RADiant Photoelectric Therapy System — Class II medical device recall Z-1404-2022
Ongoing recall by Xstrahl Limited, reported 2022-07-27, distributed in CA, FL, KY. There is a potential compatibility issue with the systems and replacement treatment applicators.
| Recall number | Z-1404-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Xstrahl Limited, Walsall, N/A, United Kingdom |
| Recall initiated | 2022-04-27 |
| Classified | 2022-07-19 |
| Reported by FDA | 2022-07-27 |
| Distributed | CA, FL, KY |
| UPC / GTIN / UDI-DI | 05060494200008 |
| Lot numbers | GM0549, GM0567, GM0568, GM0569, GM0570, GM0571, GM0577 |
| Model numbers | X80 |
Product
X80 RADiant Photoelectric Therapy System
Reason for recall
There is a potential compatibility issue with the systems and replacement treatment applicators.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1404-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.