Z-0931-2018Class II

Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names...

Name: Z-0931-2018 Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names...
Creator: Ion Beam Applications S.A.
Published: 2017-10-19
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2017-10-19 / Terminated / root cause: design

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device... on 2017-10-19. FDA classified it as Class II and gives the reason as "Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not". 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-0931-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-19
Posted: 2018-03-08
Terminated: 2019-04-02
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.
Root cause tag: design
FDA root cause: Device Design
Action: IBA sent an Urgent Field Safety Notice dated October 19, 2017 , issued to customers stating the following: IBA recommends performing a check to detect the consequence of this potential power supply regulation issue on a regular basis (IBA recommends Monthly), see Annex 1 for details. IBA is developing a corrective action in order to reduce the hysteresis effect and detect magnet current overshoot. This solution will be deployed to all systems using JEMA analog power supply. This solution will be validated and deployed by April 2018. For further questions, please call (215) 972-7985
Quantity in commerce: 3
Distribution: US Distribution to the state of :FL
Product codes and lots: PAT.003 (KR), PAT.006 (US)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0931-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0931-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-08

Product code LHN

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)