Recall Z-0938-2018 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
| Date | Nov 17, 2017 |
| Status | Terminated |
| Reason | There is a risk of misalignment of the patient when using treatment plans with multiple isocenters. |
| Root cause | Device Design |
| Action | On November 17, 2017 an Urgent Field Safety Notice was issued to customers informing users that when creating or importing a treatment plan with multiple isocenters, the user has to enter Patient Positioning System positions manually. |
| Quantity | 37 |
| Distribution | Nationally |
| 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 |