Z-0466-2022Class II

Proteus 235; Version: PTS-8 versions before PTS-8.7.2

Name: Z-0466-2022 Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Creator: Ion Beam Applications S.A.
Published: 2021-11-29
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2021-11-29 / Terminated / root cause: design

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235; Version: PTS-8 versions before PTS-8.7.2 on 2021-11-29. FDA classified it as Class II and gives the reason as "Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0466-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-29
Posted: 2022-01-07
Terminated: 2024-02-20
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where the system is using test processes without notifying the clinical user. If the versions of the processes are different between both environments, this could have an impact on patient treatments.
Root cause tag: design
FDA root cause: Device Design
Action: A Urgent Medical Device Correction notification, Ref: IBA PR-121508, was communicated to all impacted IBA customers (users of the device) on Dec 6, 2021. Action to be taken by user: 1. Please transfer this notice to other organizations on which this action has an impact. 2. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. 3. Please return the copy of the Urgent Medical Device Correction signed to IBA within 10 working days. Action by IBA: 1. IBA will upgrade the PTS version of each impacted site to a PTS version equal or superior to PTS-8.7.2. The PTS version upgrade will be deployed on your site by August 2022. 2. From PTS-8.7.2, the startup of the PTS software in the clinical environment is blocked if the shutdown of any process running in the test environment has not been successful. A message is displayed to request IBA operator to manually stop the remaining processes running in the test environment. Until the solution is implemented on your site, IBA operation team will ensure that any process running in the test environment is correctly shut down before each startup of the PTS in the clinical environment. for any question, contact Sylviane BERGER, [email protected], +32 10 203 787 or helpdesk +32 2 507 20 81 (available 24/7.
Quantity in commerce: 5 devices
Distribution: IN USA: VA, OK, NJ, TN OUS: Czech Republic.
Product codes and lots: PAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0466-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0466-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-19	2022-01-07

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)