Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2468-2018 — 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

U.S. FDA — Device Enforcement · France · 2018-06-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2468-2018
Date of alert: 2018-06-04
Country / jurisdiction: France
Risk level: Class II
Risk type: recall
Brand: Fx Solutions
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 03701037300435

Reported risk: Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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