Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized…
Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
Read the official notice →- Date
- 2024-08-28
- Country
- United States
- Brand
- Ion Beam Applications
- Product
- IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors…
- Classification
- Class II
- Units
- IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Ion Beam Applications recalls
- 2026-03-18
USIon Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235
It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal…
FDA · DeviceIon Beam Applications S.A.Worldwide - US Nationwide distribution in the state of FL and the countries of…Official notice →- 2024-09-18
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Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11…
Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
FDA · DeviceIon Beam Applications S.A.Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL,…Official notice → - 2024-06-12
- US
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized…
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
FDA · DeviceIon Beam Applications S.A.Worldwide - US Nationwide distribution in the state of Virginia and the…Official notice → - 2024-05-01
- US
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
FDA · DeviceIon Beam Applications S.A.US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.Official notice → - 2023-11-22
- US
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient…
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
FDA · DeviceIon Beam Applications S.A.Worldwide - US Nationwide distribution in the states of Arkansas, Florida,…Official notice → - 2022-06-08
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Ion Beam Applications S.A. recalls Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other…
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…
FDA · DeviceIon Beam Applications S.A.Worldwide distribution - US Nationwide distribution in the states of IL, VA,…Official notice →
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