Ion Beam Applications S.A.
Complete recall history across all FDA and CPSC categories — 36 total recalls
Ion Beam Applications S.A. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (36)
FDA medical device enforcement actions by Ion Beam Applications S.A.
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 3, 2026 | IBA Proton Therapy System - PROTEUS 235 | It was identified that eh Universal Beam Triggering Interface (UBTI) is disab... | Class II |
| Jul 10, 2024 | IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a pr... | Temporary deactivation of collision detection for Forte Robotic Patient Posit... | Class II |
| Jul 8, 2024 | IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Softwar... | Safety Parameters Verification Mechanisms can be deactivated in clinical runtime | Class II |
| May 10, 2024 | IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a p... | Irradiation is not interrupted when some C230 Accelerator Control Unit critic... | Class II |
| Mar 4, 2024 | IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, an... | There is a risk of mistreatment as irradiation is not prevented when some saf... | Class II |
| Sep 18, 2023 | IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions wit... | The patient positioning system can perform motions in unexpected directions, ... | Class II |
| Apr 20, 2022 | Proteus235- Proton Therapy System: to produce and deliver a proton beam for ... | First layer of Uniform Scanning treatment fields is sometimes irradiated with... | Class II |
| Feb 15, 2022 | ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for... | When resuming from a beam pause, the Proton Therapy System does not verify wh... | Class II |
| Nov 29, 2021 | Proteus 235; Version: PTS-8 versions before PTS-8.7.2 | Proton Therapy System (PTS) software can be started in the clinical environm... | Class II |
| Jun 14, 2021 | Proteus 235- designed to produce and deliver a proton beam for the treatment ... | Users may be misled by the popup message displayed by the Proton Therapy Syst... | Class II |
| May 26, 2021 | Proteus 235-Proton Therapy System | if the user forgets to select the trigger input manually while beam gating i... | Class II |
| Jul 17, 2020 | Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Pl... | IBA became aware of an issue to resume aborted irradiations because the plan ... | Class II |
| Apr 21, 2020 | Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus P... | Signature from the user is necessary to proceed with specific actions in the ... | Class II |
| Dec 12, 2018 | Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand... | There is a risk of detachment of the Compact Gantry Rolling Floor. | Class II |
| Jun 27, 2018 | Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with s... | Gantry rotation or proton irradiation can be allowed even if apertures or acc... | Class II |
| May 16, 2018 | Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device ... | Correction vector confirmation message is lost if access point is changed af... | Class II |
| Jan 26, 2018 | Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam f... | When switching from Pencil Beam Scanning treatment mode to Uniform Scanning t... | Class II |
| Dec 5, 2017 | Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - ... | An accessory (range shifter, ridge filter&) can be improperly inserted in sn... | Class II |
| Nov 17, 2017 | Proteus 235, Proton Therapy System a medical device designed to produce and d... | There is a risk of misalignment of the patient when using treatment plans wi... | Class II |
| Nov 1, 2017 | Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Ther... | The internal configuration of the electrometers and the Real-Time control bo... | Class II |
| Oct 19, 2017 | Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy ... | Range for the same energy could be different depending if the layer is the f... | Class II |
| Oct 17, 2017 | Proteus 235, graphite block 8 | IBA identified incorrect screw holes depth in graphite block 8 with respect t... | Class II |
| Apr 10, 2017 | Proton therapy system -Proteus 235 aka Proteus Plus. A medical device desi... | A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. Aft... | Class II |
| Mar 21, 2017 | Proteus 235, Proton Therapy System | In specific circumstances, the user is able to restart an aborted irradiation... | Class II |
| Mar 9, 2017 | Proteus 235 | The Proton Therapy System can allow gantry rotation even if the snout is not ... | Class II |
| Feb 9, 2017 | Proteus 235 | It has been observed during testing that there could be clinically non-neglig... | Class II |
| Dec 13, 2016 | Proteus 235, Proton Therapy System Product Usage: The Proton Therapy Syst... | Software issue | Class II |
| Oct 28, 2016 | 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usag... | IBA is initiating this recall to address an issue identified with AdaPTinsigh... | Class II |
| Sep 16, 2016 | 12C | IBA is initiating this recall to notify its customers that the use of non-IBA... | Class II |
| Sep 16, 2016 | Proteus ONE and Proteus Plus | IBA is initiating this recall to notify its customers that the use of non-IBA... | Class II |
| Aug 7, 2016 | Proteus 235 The PTS is a medical device designed to produce and deliver ... | IBA is recalling to provide information through a Safety Notice to reduce ris... | Class II |
| May 18, 2016 | Proteus 235 and Proteus ONE proton therapy systems | Recall is being initiated to address on-site software installations not being... | Class II |
| Apr 11, 2016 | The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteu... | IBA is conducting a voluntary recall to address a PTS (Proton Therapy System)... | Class II |
| Nov 7, 2014 | adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used wit... | Two issues were identified: 1. In the release of adaPT insight v1.3.2., ... | Class II |
| Mar 27, 2014 | Proteus 235 Proton Therapy System for cancer treatment. | While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on... | Class II |
| Dec 4, 2013 | Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, m... | Internal testing of the Proteus 235 Proton Therapy System revealed incorrect ... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
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