Z-2284-2018Class II

The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam...

Name: Z-2284-2018 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam...
Creator: Ion Beam Applications S.A.
Published: 2016-04-11
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2016-04-11 / Terminated / root cause: software

FDA source

Ion Beam Applications S.A. began a recall of The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS) on 2016-04-11. FDA classified it as Class II and gives the reason as "IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue". 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-2284-2018
Classification: Class II
Status: Terminated
Initiated: 2016-04-11
Posted: 2018-06-23
Terminated: 2020-03-25
Recalling firm: Ion Beam Applications S.A.
Product: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: IBA mailed an Urgent Field Safety Notice to affected customers to inform them and prevent risk associated with this issue. IBA also recommends users always check for any discrepancy between the prescribed and delivered MUs on their clinical screen after an irradiation in which a pause occurred. IBA also recommends users always check for any discrepancy between the prescribed and delivered MUs on their clinical screen after an irradiation in which a pause occurred. A software upgrade will be deployed on impacted units to correct this issue.
Quantity in commerce: 2
Distribution: Units were distributed to Korea and Jacksonville, FL.
Product codes and lots: PAT.003 and PAT.006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2284-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2284-2018	Class II	Terminated		2018-07-04	2018-06-23

Product code LHN

K152224Class IIProton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. / cleared 2016-08-09

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)