Z-0020-2015Class II

Proteus 235 Proton Therapy System for cancer treatment

Name: Z-0020-2015 Proteus 235 Proton Therapy System for cancer treatment
Creator: Ion Beam Applications S.A.
Published: 2014-03-27
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2014-03-27 / Terminated / root cause: design

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235 Proton Therapy System for cancer treatment on 2014-03-27. FDA classified it as Class II and gives the reason as "While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to...". 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-0020-2015
Classification: Class II
Status: Terminated
Initiated: 2014-03-27
Posted: 2014-10-29
Terminated: 2014-12-10
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235 Proton Therapy System for cancer treatment.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel.
Root cause tag: design
FDA root cause: Device Design
Action: A User Notice was sent to direct accounts in/about March/April 2014 to notify them of the issue and provide instructions to avoid the identified potential risk to patients.
Quantity in commerce: 8
Distribution: Worldwide Distribution-USA (nationwide) including the states of PA, NJ, IL, WA, and TN, and the countries of Germany, Italy, and Czech Republic.
Product codes and lots: PAT.107, PAT.109, PAT.112, PAT.113, PAT.114, PAT.115, PAT.116, PAT.119.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0020-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0020-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-29

Product code IYE

K082416Class IIIba Proton Therapy System- Proteus 235Ion Beam Applications S.A. / cleared 2008-12-12

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)