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Terminated

The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)

FDA Recall Z-2284-2018 · Posted None

Recalling FirmIon Beam Applications S.A.
Recall StatusTerminated
Product CodeLHN
Date Initiated2016-04-11
Date Terminated2020-03-25
Product Quantity2

Reason for Recall

IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.

Firm Action

IBA mailed an Urgent Field Safety Notice to affected customers to inform them and prevent risk associated with this issue. IBA also recommends users always check for any discrepancy between the prescribed and delivered MUs on their clinical screen after an irradiation in which a pause occurred. IBA also recommends users always check for any discrepancy between the prescribed and delivered MUs on their clinical screen after an irradiation in which a pause occurred. A software upgrade will be deployed on impacted units to correct this issue.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

Units were distributed to Korea and Jacksonville, 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.

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