Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
FDA Recall Z-0938-2018 · Posted None
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Recalling FirmIon Beam Applications S.A.
Recall StatusTerminated
Product CodeLHN
Date Initiated2017-11-17
Date Terminated2021-06-14
Product Quantity37
Reason for Recall
There is a risk of misalignment of the patient when using treatment
plans with multiple isocenters.
Firm Action
On November 17, 2017 an Urgent Field Safety Notice was issued to customers informing users that when creating or importing a treatment plan with multiple isocenters, the user has to enter Patient Positioning System positions manually.
Root Cause
Device Design
Distribution Pattern
Nationally
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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