Reported Aug 5, 2020 · Terminated

Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device…

Ion Beam Applications S.A.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ion Beam Applications S.A. · Chemin Du Cyclotron 3 · Louvain-la-neuve, N/A · N/A

Is this the product you have?

  • Proteus 235 The Proton Therapy
  • System - Proteus 235 (brand namesProteus 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 treatment by radiation
Lot codes and dates
  • Serial NumberManufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019
Amount recalled
2 Units

Where it was sold

Why it was recalled

IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 30, 2021 · Data as of Sep 19, 6:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.