FDA Medical Device Recalls (openFDA)
Mevion Medical Systems, Inc.: MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
- Recall number
- Z-2686-2020
- Recalling firm
- Mevion Medical Systems, Inc.
- Product
- MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
- Status
- Terminated
- Initiated
- 2020-06-23
- Posted
- not on file
- Terminated
- 2020-12-09
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K120676"]
- PMA numbers
- not on file
- Product code
- LHO
- Firm FEI
- 3007087027
- Firm city
- Littleton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28