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

Recall Z-0931-2018 — Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to trea

U.S. FDA — Device Enforcement · Belgium · 2017-10-19 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0931-2018
Date of alert: 2017-10-19
Country / jurisdiction: Belgium
Risk level: Class II
Risk type: recall
Brand: Ion Beam Applications S.A.
Product category: device
Product type: Devices

Reported risk: Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.

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.

Related