Ion Beam Applications S.A. Recall: Proteus 235 Proton Therapy System for cancer treatment.
Ion Beam Applications S.A. Recall: Proteus 235 Proton Therapy System for cancer treatment. is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Ion Beam Applications S.A.; Product: Proteus 235 Proton Therapy System for cancer treatment.; Reason for recall: While the Proteus 235 is in the pe
| Recalling firm | Ion Beam Applications S.A. |
|---|---|
| Product | Proteus 235 Proton Therapy System for cancer treatment. |
| Reason for recall | While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of PA, NJ, IL, WA, and TN, and the countries of Germany, Italy, and Czech Republic. |
| Recall initiated | 20140327 |
| Recall number | Z-0020-2015 |
| Category | device |
| State | N/A |
| Country | Belgium |
$29/mo
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