Fx SOLUTIONS CENTERED HEAD CoCr 50x19 — Class II medical device recall Z-2468-2018
Terminated recall by Fx Solutions, reported 2018-07-25, distributed nationwide. Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
| Recall number | Z-2468-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fx Solutions, Viriat Rhone-Alpes, France |
| Recall initiated | 2018-06-04 |
| Classified | 2018-07-17 |
| Reported by FDA | 2018-07-25 |
| Terminated | 2019-04-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BE, CH, CL, DE, ES, FR, GR, HK, IL, IT, LB, MX, PL, ZA |
| Quantity | 131 units |
| UPC / GTIN / UDI-DI | 03701037300435 |
| Lot numbers | K1119, K1120, K1121, K1844, K238, K240, K689R, L1730, L1737, L1748, L1756, L1764, L1820, M1042OUS |
| Model numbers | 106-5019 |
Product
Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Reason for recall
Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
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-2468-2018. 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.