FDA Device recall Z-2686-2020
MEVION S250 Proton Radiation Treatment System
- FDA Device
- Class II
- terminated
- Published 2020-07-29
On 2020-07-29 the FDA classified a Class II recall of MEVION S250 Proton Radiation Treatment System by Mevion Medical Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2686-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-23 |
| Published | 2020-07-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Mevion Medical Systems |
| Distribution | DC, FL, MO, NJ, OH, OK |
Product
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
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.
Identifiers
| code_info | Lot #s: MEVION S250-0001 MEVION S250-0002 MEVION S250-0003 MEVION S250-0004 MEVION S250-0005 MEVION S250-0006 MEV…Lot #s: MEVION S250-0001 MEVION S250-0002 MEVION S250-0003 MEVION S250-0004 MEVION S250-0005 MEVION S250-0006 MEVION S250-0007 MEVION S250-0008 UDI: (01)00864366000100 (11) 131209 (01)00864366000100 (11)150526 (01)00864366000100 (11)150113 (01)00864366000100 (11)150430 (01)00864366000100 (11)160127 (01)00864366000100 (11)160603 (01)00864366000124 (11) 180220 (01)00864366000124 (11) 181219 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2686-2020%22
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