Mevion Medical Systems, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2406-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

MEVION S250i, MEVION S250; Proton Radiation Treatment System

Product Classification:

Class II

Date Initiated: May 15, 2020

Date Posted: July 1, 2020

Recall Number: Z-2406-2020

Event ID: 85748

Reason for Recall:

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

Status: Terminated

Product Quantity: 8 units

Code Information:

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

Distribution Pattern:

Distribution to US in MO, NJ, OH, OK, FL, and DC, and the Netherlands

Voluntary or Mandated:

Voluntary: Firm initiated