RegWardenFDA facility compliance records
Recall

Class II — Ion Beam Applications S.A.

Recalling firmION BEAM APPLICATIONS S.A.
Registered facilityION BEAM APPLICATIONS S.A. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonIn specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
ProductProteus 235, Proton Therapy System
Quantity2 worldwide, 1 in U.S.
DistributionDistribution in US (to Louisiana), and France.
Initiated2017-03-21
Classified2017-04-17
Terminated2018-09-19
Recall numberZ-1830-2017
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Ion Beam Applications S.A. (Z-1830-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76804/

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