Reported May 24, 2017 · Terminated

Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for…

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

Is this the product you have?

  • Proton therapy system -Proteus 235 aka Proteus Plus. 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 numbers
    • PAT.003
    • PAT.006
Amount recalled
2

Where it was sold

Why it was recalled

A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Ion Beam Applications S.A. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 16, 2018 · Data as of Sep 19, 4:45 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.