Recall Z-1830-2017 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus 235, Proton Therapy System
| Date | Mar 21, 2017 |
| Status | Terminated |
| Reason | In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data. |
| Root cause | Software design |
| Action | A Field Safety Notice was mailed to the customer affected by the issue on 03/21/2017. The Notice informed the user when resuming from a partial irradiation, to ensure that the correct delivered dose has been selected in the partial report dialog box before proceeding with irradiation. |
| Quantity | 2 worldwide, 1 in U.S. |
| Distribution | Distribution in US (to Louisiana), and France. |
| 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 |