Z-0943-2018Class II

Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand...

Name: Z-0943-2018 Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand...
Creator: Ion Beam Applications S.A.
Published: 2017-11-01
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2017-11-01 / Terminated / root cause: design

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical... on 2017-11-01. FDA classified it as Class II and gives the reason as "The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment". 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-0943-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-01
Posted: 2018-03-09
Terminated: 2019-03-29
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 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: The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, IBA, sent an "Urgent Field Safety Notice" dated 10/31/2017 to customers on 10/31/2017. The notice described the product, problem and actions to be taken. stating the following: There is no specific recommendation for the user. IBA will provide an Internal User notice to the IBA site team, requesting the operator to select the Beam Delivery Point CGTR, by clicking on the BDP button, before each patient treatment preparation (see Annex 1 for details). This will begin the check of the internal configuration of all the elements of the Dekimo Scanning Controller. An updated system will be deployed on February 28, 2017. If you have any questions, contact Customer Complaints & Vigilance Director at [email protected] or +32 10 203 787 or helpdesk at +32 2 507 20 81 (available 24/7).
Quantity in commerce: 3
Distribution: Worldwide Distribution: US (nationwide) to: MI only and country of: France.
Product codes and lots: SBF.101 (EU), SBF.105 (US)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0943-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0943-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09

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