Z-0295-2024Class II

IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0...

Name: Z-0295-2024 IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0...
Creator: Ion Beam Applications S.A.
Published: 2023-09-18
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2023-09-18 / Open, Classified / root cause: design

FDA source

Ion Beam Applications S.A. began a recall of IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System on 2023-09-18. FDA classified it as Class II and gives the reason as "The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0295-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-18
Posted: 2023-11-14
Recalling firm: Ion Beam Applications S.A.
Product: IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Medical Device Correction issued on October 4, 2023 by email or in-person visit. Waiting for the solution to be deployed, IBA requires the user to only request jog translation motions to recover from a collision situation. IBA also recommends the user to post the notice near the device to remind them of this requirement until the software correction can be deployed. IBA provide an updated Urgent Medical Device Correction notification by November 30, 2023 with a target date for deployment of the software solution to your site. Customers are to complete and return the acknowledgement form to IBA. IBA Contact: Sonia Pinel Head of Post Market Vigilance, Email: [email protected], Helpdesk: +32 2 507 20 81 (available 24/7).
Quantity in commerce: 5 (US), 9 (OUS)
Distribution: Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan.
Product codes and lots: UDI-DI: (01)05404013801138. Serial numbers (US): SAT133, SAT140, SBF113, SBF128, SBF135 & (OUS): SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, & SBF125.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0295-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0295-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-22	2023-11-14

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)