Z-3089-2024Class II

IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10...

Name: Z-3089-2024 IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10...
Creator: Ion Beam Applications S.A.
Published: 2024-07-08
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2024-07-08 / Open, Classified

FDA source

Ion Beam Applications S.A. began a recall of IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions on 2024-07-08. FDA classified it as Class II and gives the reason as "Safety Parameters Verification Mechanisms can be deactivated in clinical runtime". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3089-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-08
Posted: 2024-09-10
Recalling firm: Ion Beam Applications S.A.
Product: IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
FDA root cause: Under Investigation by firm
Action: IBA issued AMENDED Urgent Medical Device Correction letter (IBA REFERENCE NCIPT-27531) on 7/10/24 provided by IBA directly to the customer either by hand or by email. Letter states reason for recall, health risk and action to take: Regarding Proteus 235 with a PTS-8, PTS-10, PTS-11 or PTS-12 versions: actions: Regarding the malfunction of Safety Parameters Verification Mechanism within BAPP . IBA carried out an analysis to determine if the impacted sites have some safety parameters checked by the BAPP in their clinical site configuration with values leading to violations. The result of this analysis showed that there are no sites with safety parameters checked by the BAPP out of tolerance. Regarding the possibility to disable a Safety Parameters Verification Mechanism (concerns PTS-8, PTS-10, PTS-11 or PTS-12 versions): IBA will carry out an analysis to determine if the impacted sites have specific configuration parameters that allow to deactivate the Safety Parameters Verification Mechanisms in the clinical configuration and if the case, remove them from the clinical site configuration. The result of the analysis will be provided to you on July 31, 2024, at the latest. Final solutions: Regarding the malfunction of Safety Parameters Verification Mechanism within BAPP (only concerns PTS-10, PTS-11 or PTS-12 versions): IBA will ensure that the system cannot be used in clinical with safety parameters checked by the BAPP out of tolerances. Regarding the possibility to disable a Safety Parameters Verification Mechanism (concerns PTS-8, PTS-10, PTS-11 or PTS-12 versions): IBA will ensure that the system displays a Red Banner informing the customer that the system must not be used for clinical activities when safety parameter Verification Mechanisms are deactivated to prevent the users from treating patients. The intermediate action will be implemented for your site by August 31, 2024, at the latest. The final solution will be implemented for your site by June 2026. Fi
Quantity in commerce: 35 units
Distribution: Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL, KA, IL, LA, MI, TN , TX, VA and the countries of BE, CZ, DE, ES, FR, IN, IT, JP, NL, PL, RU, SE, SG, TW.
Product codes and lots: UDI-DI: 05404013801138 Serial Numbers: PAT.107 (DE), PAT.108 (US), PAT.109 (US), PAT.110 (US), PAT.111 (FR), PAT.112 (US), PAT.113 (US), PAT.114 (CZ), PAT.115 (IT), SAT.116 (US), SAT.117 (PL), SAT.118 (RU), SAT.119 (US), SAT.120 (DE), SAT.122 (SE), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.127 (TW), SAT.132 (NL), SAT.133 (US), SAT.136 (IN), SAT.140 (US), SBF.101 (FR), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (FR), SBF.112 (BE), SBF.113 (US), SBF.117 (ES), SBF.124 (IT), SBF.125 (SG), SBF.128 (US), SBF.135 (US).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3089-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3089-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-10

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)