Recall Z-0020-2015 ยท IYE Accelerator, Linear, Medical
Ion Beam Applications S.A.
Proteus 235 Proton Therapy System for cancer treatment.
| Date | Oct 29, 2014 (initiated Mar 27, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | A User Notice was sent to direct accounts in/about March/April 2014 to notify them of the issue and provide instructions to avoid the identified potential risk to patients. |
| Quantity | 8 |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of PA, NJ, IL, WA, and TN, and the countries of Germany, Italy, and Czech Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082416 | IBA PROTON THERAPY SYSTEM- PROTEUS 235 Ion Beam Applications S.A., Dec 12, 2008 |