Ion Beam Applications S.A.: FDA recalls

FDA enforcement reports name Ion Beam Applications S.A. as the recalling firm in 35 events. The events have 36 product records. The recalls started from 2013 to 2026. All the events are device recalls.

See the 35 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

35 events, newest first.

FDA enforcement events of Ion Beam Applications S.A.
Initiated	Product (first record)	Type	Class	Records	Status
3 Feb 2026	IBA Proton Therapy System - PROTEUS 235	Device	Class II	1	Ongoing
10 Jul 2024	IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation	Device	Class II	1	Ongoing
8 Jul 2024	IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions	Device	Class II	1	Ongoing
10 May 2024	IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.	Device	Class II	1	Ongoing
4 Mar 2024	IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.	Device	Class II	1	Ongoing
18 Sep 2023	IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.	Device	Class II	1	Ongoing
20 Apr 2022	Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation	Device	Class II	1	Ongoing
15 Feb 2022	ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235	Device	Class II	1	Ongoing
29 Nov 2021	Proteus 235; Version: PTS-8 versions before PTS-8.7.2	Device	Class II	1	Terminated
14 Jun 2021	Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation	Device	Class II	1	Ongoing
26 May 2021	Proteus 235-Proton Therapy System	Device	Class II	1	Ongoing
17 Jul 2020	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.	Device	Class II	1	Terminated
21 Apr 2020	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.	Device	Class II	1	Terminated
12 Dec 2018	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…	Device	Class II	1	Terminated
27 Jun 2018	Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver 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…	Device	Class II	1	Terminated
16 May 2018	Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A 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.	Device	Class II	1	Terminated
26 Jan 2018	Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.	Device	Class II	1	Terminated
5 Dec 2017	Proteus 235, Uniform and Pencil Beam Scanning 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…	Device	Class II	1	Terminated
17 Nov 2017	Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.	Device	Class II	1	Terminated
1 Nov 2017	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…	Device	Class II	1	Terminated
19 Oct 2017	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.…	Device	Class II	1	Terminated
17 Oct 2017	Proteus 235, graphite block 8	Device	Class II	1	Terminated
10 Apr 2017	Proton therapy system -Proteus 235 aka Proteus Plus. 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.	Device	Class II	1	Terminated
21 Mar 2017	Proteus 235, Proton Therapy System	Device	Class II	1	Terminated
9 Mar 2017	Proteus 235	Device	Class II	1	Terminated
9 Feb 2017	Proteus 235	Device	Class II	1	Terminated
13 Dec 2016	Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 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…	Device	Class II	1	Terminated
28 Oct 2016	12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system.	Device	Class II	1	Terminated
16 Sep 2016	12C	Device	Class II	2	Terminated
7 Aug 2016	Proteus 235 The PTS 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…	Device	Class II	1	Terminated
18 May 2016	Proteus 235 and Proteus ONE proton therapy systems	Device	Class II	1	Terminated
11 Apr 2016	The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)	Device	Class II	1	Terminated
7 Nov 2014	adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device.	Device	Class II	1	Terminated
27 Mar 2014	Proteus 235 Proton Therapy System for cancer treatment.	Device	Class II	1	Terminated
4 Dec 2013	Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Ion Beam Applications S.A.: events for each product type
Type		Events
Device		35

Ion Beam Applications S.A.: events in each class
Class		Events
Class II		35

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 10

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Ion Beam Applications S.A., by the year that the recall started. The largest year is 2017, with 9 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Ion Beam Applications S.A.: FDA recalls. https://recallregister.com/firm/ion-beam-applications-s-a/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: N/A

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Ion Beam Applications S.A. have?: Class II: 35 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Ion Beam Applications S.A.?: FDA event 98364, which the firm started on 3 Feb 2026. The first product in the record is: IBA Proton Therapy System - PROTEUS 235
How many FDA recalls of Ion Beam Applications S.A. have the status Ongoing?: 10 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.