Recall Z-2155-2021 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus 235-Proton Therapy System
| Date | May 26, 2021 |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Labeling design |
| Action | IBA issued Urgent Medical Device Correction notification starting on May 27, 2021. Letter states reason for recall, health risk and action to take: IBA would like to remind Proteus235 users of the following warning present in the Clinical User Guide: As a Radiation Therapy Technologist (RTT), check before allowing the irradiation that the position of the selector switch of the external beam triggering interface is consistent with the prescription data in the patient file. There is a risk of mistreatment as the system does not automatically detect the gating prescription thereby always genera |
| Quantity | 5 US; 8 OUS |
| Distribution | FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101508 | MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 Ion Beam Applications S.A., Aug 6, 2010 |