| 2022-02-01 |
Class II
|
Ongoing |
Z-0827-2022 |
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) |
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Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come… |
| 2020-10-19 |
Class II
|
Terminated |
Z-0485-2021 |
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treat… |
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Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur |
| 2020-06-23 |
Class II
|
Terminated |
Z-2686-2020 |
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients |
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The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury… |
| 2020-05-15 |
Class II
|
Terminated |
Z-2406-2020 |
MEVION S250i, MEVION S250; Proton Radiation Treatment System |
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Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes … |