Company:Ion Beam Applications S.A
Date of Enforcement Report 4/30/2014
Class lI:
PRODUCT
Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy Recall Number Z-1492-2014
REASON
Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).
RECALLING FIRM/MANUFACTURER
Ion Beam Applications S.A, Louvain La Neuve, BE on 12/4/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4
DISTRIBUTION
Nationwide
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