Data Foundry

Medical device recalls 2018

Fx SOLUTIONS OFFSET HEAD CoCr 50x20 — Class II medical device recall Z-2469-2018

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 numberZ-2469-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmFx Solutions, Viriat Rhone-Alpes, France
Recall initiated2018-06-04
Classified2018-07-17
Reported by FDA2018-07-25
Terminated2019-04-05
DistributedNationwide (US)
Countries outside the USAR, BE, CH, CL, DE, ES, FR, GR, HK, IL, IT, LB, MX, PL, ZA
Quantity145 units
UPC / GTIN / UDI-DI03701037300510
Lot numbersJ1123, K1117, K1118, K1418, K1419, K1625, K231, K232, K233, K234, K235, L1271, L1272, L1727, L1729, L1736, L1747, L1755, L1819, M1041
Model numbers106-5000

Product

Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 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-2469-2018. 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.