Reported Jun 12, 2024 · Ongoing

IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients…

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 - 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
  • UDISAT140: (01)05404013814015(11)190507(21)SAT140
  • SAT136(01)05404013801138(11)201105(21)SAT136
  • Serial NumbersSAT136, SAT140 PTS-11 versions from PTS-11.1 and PTS-12 versions, with C230 accelerator
Amount recalled
2 units

Where it was sold

  • Nationwide
  • VA

Why it was recalled

Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances

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, 6:57 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.