Recall Z-2097-2017 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
| Date | May 3, 2017 (initiated Apr 10, 2017) |
| Status | Terminated |
| Reason | A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose. |
| Root cause | Software design |
| Action | Target date for software update June 30, 2017. A Field Safety Notice was issued on 4/10/2017 describing the problem and reminding users to follow guidance in the user's manual. |
| Quantity | 2 |
| Distribution | FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) Ion Beam Application S.A., Aug 9, 2016 |