Recall Z-0705-2019 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Mevion Medical Systems, Inc.
MEVION S250i
| Date | Oct 1, 2018 |
| Status | Terminated |
| Reason | Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped |
| Root cause | Software Manufacturing/Software Deployment |
| Action | On-site Mevion Field Service Engineer communicated with the firm and is in daily communication with the single affected consignee. |
| Quantity | 1 unit |
| Distribution | DC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172848 | MEVION S250i Proton Beam Radiation Therapy Device Mevion Medical Systems, Dec 27, 2017 |