Z-0698-2019Class II

Proteus 235

Name: Z-0698-2019 Proteus 235
Creator: Ion Beam Applications S.A.
Published: 2018-12-12
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2018-12-12 / Terminated / root cause: design

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and... on 2018-12-12. FDA classified it as Class II and gives the reason as "There is a risk of detachment of the Compact Gantry Rolling Floor". 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-0698-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-12
Posted: 2019-01-08
Terminated: 2020-04-15
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235 Product Usage: 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: There is a risk of detachment of the Compact Gantry Rolling Floor.
Root cause tag: design
FDA root cause: Device Design
Action: On December 12, 2018, the firm notified its customers of the recall via an Urgent Medical Device Correction letter. Customers were informed of the product issue. Customers were reminded that nobody should stand on the rolling floor when the gantry is rotating, as specified in the Clinical User Guide. The recalling firm stated they would take the following actions: Short-term action: IBA will replace the rod end bearings attaching the cGRF to the nozzle via a preventive maintenance on all ProteusONE sites. Long-term action: A new design of the anchoring system of the cGRF to the nozzle will be deployed on all impacted sites via an upgrade kit by end of October 2019. Customers with questions should contact Sylviane BERGER [email protected] +32 10 203 787, or Helpdesk +32 2 507 20 81 (available 24/7)
Quantity in commerce: 7
Distribution: Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK.
Product codes and lots: SAT.123, SBF.101, SBF.103, SBF.104, SBF.105, SBF.107, SBF.109

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0698-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0698-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-16	2019-01-08

Product code LHN

K091629Class IIProteus 235 Proton Therapy SystemIon Beam Applications S.A. / cleared 2009-08-11

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)