Recall Z-2686-2020 ยท LHO Instrument, Quality-Assurance, Radiologic
Mevion Medical Systems, Inc.
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
| Date | Jun 23, 2020 |
| Status | Terminated |
| Reason | 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 for servicer. |
| Root cause | Device Design |
| Action | This screen would not be accessed by normal user (only servicer). Firm is notifying servicing personnel and not consumer/user level. No customer letters/communication sent. Servicer will install edge guard on effected units. Technical Service Bulletin issued to servicer. |
| Quantity | 8 units |
| Distribution | MO, NJ, OK, FL, OH, DC, Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120676 | S-250 PROTON BEAM RADIATION THERAPY SYSTEM Mevion Medical Systems, Jun 4, 2012 |