Z-2693-2024Class II

IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of...

Name: Z-2693-2024 IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of...
Creator: Ion Beam Applications S.A.
Published: 2024-07-10
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2024-07-10 / Open, Classified / root cause: manufacturing process

FDA source

Ion Beam Applications S.A. began a recall of IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions... on 2024-07-10. FDA classified it as Class II and gives the reason as "Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2693-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-10
Posted: 2024-08-21
Recalling firm: Ion Beam Applications S.A.
Product: IBA Proton Therapy System - PROTEUS 235- 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: Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
Root cause tag: manufacturing process
FDA root cause: Process design
Action: IBA isued Urgent Medical Device Correction letter on July 10, 2024. Letter states reason for recall, health risk and action to take: IBA would like to remind you as IBA Proton Therapy System -PROTEUS 235 user of the warnings present in your Clinical User's Guide which emphasize the importance of carefully monitoring the patients behavior during the different treatment phases. IBA would like to also remind you that the manual hand crank could be used by the system operator for the emergency release of the Patient Positioning System in the situations listed in the Clinical User's Guide and Accelerator Operator's Guide and by following the instructions described in both guides. To be signed and given back to IBA representative on site. PTS-8, PTS-10 and PTS-11 versions: Software upgrade IBA will update the software of the Positioning Management System in order that, after a collision, the request to temporarily disable the collision detection will be sent until the status of the collision detection is well disabled. This solution will be deployed at your site by March 2026. PTS-12 versions: users training and labeling change IBA will provide customer training on the system behavior in PTS-12 versions following collision detections. Additionally, IBA will update the labeling to clarify that users can also move the snout or gantry to go out collision situations. These solutions will be deployed at your site by January 2025
Quantity in commerce: 19 units
Distribution: IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden
Product codes and lots: UDI-DI: (01)05404013801138 Serial Numbers; PAT.108 (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.126 (US), SBF.101 (FR), SBF.103 (JP), SBF.104 (JP), SBF.105(US).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2693-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2693-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-28	2024-08-21

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)