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
___________________________________
