Reported May 1, 2024 · Ongoing

IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.

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 · Ottignies-Louvain-La-Neuve, N/A · N/A

Is this the product you have?

    • IBA Proton Therapy System - PROTEUS 235
    • PTS-10 versions
    • PTS-11 versions
    • and PTS-12 versions
Lot codes and dates
    • PTS-10 versions
    • PTS-11 versions
    • and PTS-12 versions
  • UDI-DI05404013801138
  • Serial Numbers
    • SAT.123
    • SAT.126
    • SAT.133
    • SAT.140
    • SBF.105
    • SBF.113
    • SBF.128
    • SBF.135. All configurations
Amount recalled
8 units

Where it was sold

Why it was recalled

There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.

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

Data as of Sep 19, 6:56 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.