Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
FDA Recall Z-0934-2018 · Posted None
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Recalling FirmIon Beam Applications S.A.
Recall StatusTerminated
Product CodeLHN
Date Initiated2017-12-05
Date Terminated2019-03-29
Product Quantity14
Reason for Recall
An accessory (range shifter, ridge filter&) can be improperly inserted in
snout 300x400 with one rail only and the proton therapy system can still
operate.
Firm Action
Ion Beam Applications (IBA) sent an Urgent Field Safety Notice dated December 5, 2017, to customers informing them of the issue and request that all users verify that the accessory is correctly inserted in snout 300x400 with both rails in the guide. A solution to this issue including a hardware modification will be deployed on or before March 31, 2018. For further questions, please call (215) 972-7985.
Root Cause
Device Design
Distribution Pattern
US Distribution to the states of : MA, FL, VA, PA, OK, TN
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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