FDA Medical Device Recalls (openFDA)
Mevion Medical Systems, Inc.: MEVION S250i, MEVION S250; Proton Radiation Treatment System
- Recall number
- Z-2406-2020
- Recalling firm
- Mevion Medical Systems, Inc.
- Product
- MEVION S250i, MEVION S250; Proton Radiation Treatment System
- Status
- Terminated
- Initiated
- 2020-05-15
- Posted
- not on file
- Terminated
- 2020-12-11
- Reason
- 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 turned off
- Root cause
- Software design
- Action
- Mevion issued letter (pCAR0012) on May 15, 2020 via mail or FedEx, with return receipt confirmation. Letter states reason for recall, health risk and action to take: Until a software fix is applied for this problem, the user is cautioned to carefully pay attention to the 3 indicators of Couch corrections. If they disagree with the intended moves the user may simply repeat the alignment step and the problem should clear. Required User Action When using multimodal imaging the user should always check the indicators for Couch Corrections before they are applied. This includes the Verity Couch Correction widget, the Verity dialog box the informs the user of the actions being sent to the Couch, and the In Room Monitor lower right panel that displays the moves before they are made. If these disagree with the intended moves, the user should back up a step and resend the corrections. Users must confirm positioning for every applied Couch correction that all intended moves are indicated and made.
- Quantity
- 8 units
- Distribution
- Distribution to US in MO, NJ, OH, OK, FL, and DC, and the Netherlands
- Lot, serial or model codes
- Serial Numbers: 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","K172848"]
- PMA numbers
- not on file
- Product code
- LHN
- 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