Z-2715-2020Class II

Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical...

Name: Z-2715-2020 Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical...
Creator: Ion Beam Applications S.A.
Published: 2020-07-17
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2020-07-17 / Terminated / root cause: software

FDA source

Ion Beam Applications S.A. began a recall of Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton... on 2020-07-17. FDA classified it as Class II and gives the reason as "IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded". 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-2715-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-17
Posted: 2020-07-27
Terminated: 2021-08-30
Recalling firm: Ion Beam Applications S.A.
Product: Proteus 235 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.
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Medical Device Correction notification will be communicated to all impacted IBA customers (users of the device), starting July 23, 2020. This letter instructs the customer: If this situation were to occur, it is recommended to complete the aborted treatment in Standalone Mode (please refer to the steps described in annex I and to the part Using adaPTdeliver in Standalone Mode of the Proton Therapy System Clinical Users Guide). IBA will modify the software to remove conditions that make impossible to load the plan to complete the aborted treatment. The solution will be deployed on your site by June 30, 2022.
Quantity in commerce: 2 Units
Distribution: US: VA OUS: Belgium
Product codes and lots: Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2715-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2715-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-05	2020-07-27

Product code LHN

K163500Class IIIBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)Ion Beam Applications S.A. / cleared 2017-08-17

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)