Z-2424-2018Class II

Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2

Name: Z-2424-2018 Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2
Creator: Ion Beam Applications S.A.
Published: 2018-05-16
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2018-05-16 / Terminated / root cause: software

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with... on 2018-05-16. FDA classified it as Class II and gives the reason as "Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2424-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-16
Posted: 2018-06-20
Terminated: 2018-10-16
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device 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: Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.
Root cause tag: software
FDA root cause: Software design
Action: On May 18, 2018 IBA issued URGENT FIELD SAFETY NOTICES to their customers. Customers were advised to take the following actions: It is recommended to ensure that the correction vector confirmation message appears on the expected access point. When the correction vector is applied (if deemed necessary1), ensure that the Patient Positioning System GoTo the corrected position for treatment before starting irradiation: - verify on adaPTdeliver screen that the corrected target position is selected before engaging the movement. - verify on adaPTdeliver screen that the corrected target position appears on the screen after the movement. Moreover, as advised in the Proton Therapy System Clinical User Guide, it is recommended to verify the patient position after each correction vector application. A software update will be deployed on all affected sites by July 2018. Customers with questions may email: [email protected]
Quantity in commerce: 3 units
Distribution: Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands
Product codes and lots: Serial Numbers: SAT.122 (EU) SAT.132 (EU) SAT.133 (US)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2424-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2424-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-11

Product code LHN

K101508Class IIModification to Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. / cleared 2010-08-06

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)