Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-2097-2017 · Posted 2017-05-03

Recalling FirmIon Beam Applications S.A.
Recall StatusTerminated
Product CodeLHN
Date Initiated2017-04-10
Date Terminated2018-02-16
Product Quantity2

Reason for Recall

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.

Firm Action

Target date for software update June 30, 2017. A Field Safety Notice was issued on 4/10/2017 describing the problem and reminding users to follow guidance in the user's manual.

Root Cause

Software design

Distribution Pattern

FL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. · 2016-08-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑