Z-1603-2024Class II

IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions

Name: Z-1603-2024 IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions
Creator: Ion Beam Applications S.A.
Published: 2024-03-04
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2024-03-04 / Open, Classified / root cause: design

FDA source

Ion Beam Applications S.A. began a recall of IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions on 2024-03-04. FDA classified it as Class II and gives the reason as "There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance". 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-1603-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-04
Posted: 2024-04-19
Recalling firm: Ion Beam Applications S.A.
Product: IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
Root cause tag: design
FDA root cause: Device Design
Action: On 3/20/2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers in person or via email by their customer representative. Customers were instructed to review the notice with their customer representative. Immediate actions taken: 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. Intermediate action: While waiting for the solution to be deployed on your site, a regular automatic check that the safety parameters are within tolerances will be implemented. IBA will distribute an Internal User Notice to IBA operators of impacted sites to inform them that operators shall monitor alarms triggered by this check and directly inform you if a violation is detected. The intermediate action will be implemented for your site by April 30th, 2024, at the latest. The final solution will be implemented for your site by December 2025.By signing the response form, the customer representative confirms that this notice has been read, understood and communicated to the appropriate employees within the organization. Please transfer this notice to other organizations on which this action has an impact. Please maintain awareness of this notice and the resulting action for an appropriate period to ensure the effectiveness of the corrective action. The Food and Drug Administration has been informed of this Urgent Medical Device Correction. We apologize for any inconvenience that this may cause, and we would like to thank you for your cooperation. Your IBA representative can provide you with additional information and/or guidelines if necessary. Please contact Sonia Pinel, Head or Post Market Vigilance at +32 10 497 516 or [email protected] or the helpdesk +32 2 507 20 81 (available 24/7).
Quantity in commerce: 8 units
Distribution: US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.
Product codes and lots: PTS-10 versions, PTS-11 versions, and PTS-12 versions. UDI-DI: 05404013801138; Serial Numbers: SAT.123, SAT.126, SAT.133, SAT.140, SBF.105, SBF.113, SBF.128, SBF.135. All configurations.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1603-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1603-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-19

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)