Ion Beam Applications S.A.: Proteus 235 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.

Recall number

Z-2773-2020

Recalling firm

Ion Beam Applications S.A.

Product

Proteus 235 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.

Status

Terminated

Initiated

2020-04-21

Posted

not on file

Terminated

2021-09-01

Reason

Signature from the user is necessary to proceed with specific actions in the Proton Therapy System (PTS). IBA became aware that the PTS does not accept user names with more than ten characters. It is an issue when the user has no other choice than resuming an aborted treatment field based on the overall delivered dose displayed on the Dose Counter Electronic Unit (DCEU). User s signature is required to perform this action. If the signature contains more than ten characters, the user will not be able to complete the aborted treatment field. An additional issue applies to Electronic Medical Record (EMR) centric sites and may increase the probability of not being able to complete an aborted treatment field. It is not possible, in a new session, to resume from a local partial archive if the Patient Positioning System (PPS) position has changed. If the user captures the PPS position at every session in the Oncology Information System (OIS) just after the setup process, the prescribed PPS position is changed for the next session in the OIS. This includes the partial continuation session. Therefore, when comparing the prescribed PPS position between OIS and local database, the PTS sees a difference and rejects the local partial archive. This problem forces the user to resume the interrupted irradiation based on the overall delivered dose displayed on the DCEU instead of resuming from the full details of the interrupted beam.

Root cause

Software design

Action

IBA sent a customer communication letter dated May 8, 2020. This letter explained to the customers, it is recommended to redefine any user name that contains more than ten characters to a user name with up to ten characters. Software upgrade IBA will remove the limitation on the allowed length of the user name in the database. IBA will modify the list of criteria that guarantee proper matching between the treatment field being resumed and the treatment field that was interrupted: patient position from the beam report will be used instead of the PPS position. The solutions will be deployed on your site by February 1, 2021.

Quantity

4 units

Distribution

Worldwide distribution - US Nationwide distribution including in the states of FL, VA and the countries of Belgium, Spain.

Lot, serial or model codes

Serial Number: Manufacture date  SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019 SBF.113 (US): manufactured June 2019 SBF.117 (EU): manufactured November 2019

510(k) numbers

["K163500"]

PMA numbers

not on file

Product code

LHN

Firm FEI

3000256071

Firm city

Louvain-la-neuve

Firm state

not on file

Firm country

Belgium

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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