Recall Z-0485-2021 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Mevion Medical Systems, Inc.
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation
| Date | Oct 19, 2020 |
| Status | Terminated |
| Reason | Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur |
| Root cause | Device Design |
| Action | Mevion issued User Notice by mail or FedEx, with return receipt confirmation on October 22, 2020. The letter states reason for recall, health risk and action to take: The User should actively monitor the TC screen during beam delivery. In the event the TC screen beam information appears blank during Beam On, the user should: Immediately suspend treatment by selecting Beam Off on the Beam Control Box. Record the MU counts displayed on the HMUC before any other action is taken. Consult physics to make manual adjustments of the plan. Notify Field Service to retrieve machine records of the pa |
| Quantity | 8 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of DC, FL, MO, NJ, OK and the country of Netherlands. |
| 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 |