Recall Z-0747-2022 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
| Date | Feb 15, 2022 |
| Status | Open, Classified |
| Reason | 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 modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range |
| Root cause | Device Design |
| Action | IBA issued Urgent Medical Device Correction notification on February 15, 2022 directly to customer either by hand or by email. Letter states reason for recall, health risk and action to take: For Proton Therapy sites where the system is operated by the customer: - Warn operators to not manually change the beam range (action called manual set range ) while a patient is on the Patient Positioning System. - IBA will provide a training to all operators about the correct use of the action called manual set range and the risk associated to its use while a patient is on the Patient Positioning S |
| Quantity | 15 units US; 22 units OUS |
| Distribution | IL, KS, LA, FL, MI, OK, PA, NJ, TN, TX, VA, WA Foreign: Belgium, England, Germany, France, Czech Republic, Italy, Poland, Russia, Spain, Sweden, South Korea, Taiwan, Netherlands, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) Ion Beam Applications S.A., Aug 17, 2017 |