Treatment applicator for Gulmay Medical 150 or Xstrahl 150… — Class II medical device recall Z-0389-2022
Terminated recall by Xstrahl Limited, reported 2021-12-22. Base plate may detach from the main body of the treatment applicator.
| Recall number | Z-0389-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Xstrahl Limited, Walsall, United Kingdom |
| Recall initiated | 2021-08-27 |
| Classified | 2021-12-16 |
| Reported by FDA | 2021-12-22 |
| Terminated | 2026-03-04 |
| Countries outside the US | AT, AU, BG, CA, CH, CR, CY, DE, DK, DZ, ES, FR, GB, HK, HR, IE, IT, LV, MT, MX, NO, NZ, PA, RO, RU, SA, SE, UA |
| Quantity | 120 applicators |
| Reason classes | device malfunction |
Product
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Reason for recall
Base plate may detach from the main body of the treatment applicator.
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-0389-2022. 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.