Reported Apr 26, 2017 · Terminated

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 NumberSAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0
Amount recalled
2 worldwide, 1 in U.S.

Where it was sold

Why it was recalled

In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.

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 Sep 19, 2018 · Data as of Sep 19, 5:22 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.