Z-2773-2020Class II

Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical...

Name: Z-2773-2020 Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical...
Creator: Ion Beam Applications S.A.
Published: 2020-04-21
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2020-04-21 / Terminated / root cause: software

FDA source

Ion Beam Applications S.A. began a recall of 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... on 2020-04-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2773-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-21
Posted: 2020-08-07
Terminated: 2021-09-01
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.
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: 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 tag: software
FDA 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 in commerce: 4 units
Distribution: Worldwide distribution - US Nationwide distribution including in the states of FL, VA and the countries of Belgium, Spain.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2773-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2773-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-07

Product code LHN

K163500Class IIIBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)Ion Beam Applications S.A. / cleared 2017-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)