Company: Ion Beam Applications S.A .
Date of Enforcement Report 5/24/2017
Class lI:

PRODUCT

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.
Recall Number Z-2097-2017

REASON
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

RECALLING FIRM/MANUFACTURER
Ion Beam Applications S.A., Louvain La Neuve, Belgium on 4/10/2017. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
2

DISTRIBUTION
FL

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