Company: Ion Beam Applications S.A..
Date of Enforcement Report 7/12/2017
Class lI:
PRODUCT
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System – Proteus 235 is 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-2684-2017
REASON
Software issue.
RECALLING FIRM/MANUFACTURER
Ion Beam Applications S.A., Louvain La Neuve, Belgium on 12/13/2016. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
6 worldwide and 5 in the U.S.
DISTRIBUTION
Distributed to FL, VA, IL, NJ, WA and South Korea
___________________________________