Ion Beam Applications S.A. Chemin Du Cyclotron 3 Ottignies-Louvain-La-Neuve Belgium Recalls

All product recalls associated with Ion Beam Applications S.A. Chemin Du Cyclotron 3 Ottignies-Louvain-La-Neuve Belgium.

Get alerts for this brand

Recall Summary

Total Recalls

8

Past Year

0

Class I (Serious)

0

Most Recent

Jul 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–8 of 8 recalls

Proton Therapy System (IBA) – Positioning System Issue (2024)

Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues

Moderate

FDAJul 10, 2024IL, LA, MI +6 more• Ion Beam Applications S.A. Chemin Du Cyclotron 3 Ottignies-Louvain-La-Neuve Belgium

Proteus235 Proton Therapy (Ion Beam) – scanning magnet issue (2022)

First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed

FDAApr 20, 2022Nationwide• Ion Beam Applications S.A. 3 Chemin Du Cyclotron Louvain-la-neuve Belgium

ProteusPLUS (Ion Beam) – proton beam pause verification (2022)

When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range

FDAFeb 15, 2022FL, IL, KS +9 more• Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium

Proteus 235 (Ion Beam) – Software Environment Risk (2021)

Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where the system is using test processes without notifying the clinical user. If the versions of the processes are different between both environments, this could have an impact on patient treatments.

FDANov 29, 2021IN, NJ, OK +2 more• Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium

Proteus 235 Proton System (Ion Beam Applications) – Popup Message Issue (2021)

Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment

FDAJun 14, 2021Nationwide• Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium

Proteus Therapy System (Ion Beam) – Beam Gating Issue (2021)

if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position

FDAMay 26, 2021FL, PA, TN +2 more• Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium

Proteus 235 (Ion Beam Applications) - Treatment Resumption Issue (2020)

IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.

FDAJul 17, 2020VA• Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium

Ion Beam Applications S.A.: adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment roo...

Two issues were identified: 1. In the release of adaPT insight v1.3.2., the kV/kV Single Source acquisition workflow was linked to a wrong geometrical calibration file, resulting in an alignment offset for this specific mode of acquisition. 2. A gantry collision incident required the IBA service team to verify the gantry alignment and protons I x-ray beams colinearity, du

Class IIModerate

FDANov 7, 2014IN, PA• Ion Beam Applications S.A.

Stay Informed