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…
Read the official notice →- Date
- 2022-06-08
- Country
- United States
- Brand
- Ion Beam Applications
- Product
- Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of IL, VA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-08-28
USIon 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
FDA · DeviceIon Beam Applications S.A.IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy…Official notice →- 2024-06-12
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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 → - 2022-03-16
- US
Ion Beam Applications S.A. recalls ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and…
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…
FDA · DeviceIon Beam Applications S.A.IL, KS, LA, FL, MI, OK, PA, NJ, TN, TX, VA, WA Foreign: Belgium, England,…Official notice → - 2022-01-19
- US
Ion Beam Applications S.A. recalls Proteus 235; Version: PTS-8 versions before PTS-8.7.2
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…
Other drugs & medical recalls in the United States
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Intuitive Surgical, Inc. recalls VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
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Bio-Rad Laboratories, Inc. recalls Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
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FDA · DeviceBio-Rad Laboratories, Inc.US: AZ, AR, GA, CO, TN, LA, VA, FL, KY, IN, KS, MD, MN, MO, NC, NJ, NY, OH,…Official notice → - US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the…
The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
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Busse Hospital Disposables, Inc. recalls 3.2MM Pellet Insertion Tray Catalog Number: B9743
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Baxter Healthcare Corporation recalls 3,65 m Extension Set with Luer-lock Connector
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