Reported Aug 4, 2021 · Ongoing

Proteus 235-Proton Therapy System

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-Proton Therapy System
Lot codes and dates
  • Serial Numbers
    • PAT.107 (EU)
    • PAT.108 (US)
    • PAT.109 (US)
    • PAT.115 (EU)
    • SAT.117 (EU)
    • SAT.118 (RU)
    • SAT.119 (US)
    • SAT.120 (EU)
    • SAT.122 (EU)
    • SAT.125 (IN)
    • SAT.126 (US)
    • SAT.132 (EU)
    • SAT.133 (US)
Amount recalled
5 US; 8 OUS

Where it was sold

Why it was recalled

if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position

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, 4:53 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.