Mevion Medical Systems, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2686-2020)

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 S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients

Product Classification:

Class II

Date Initiated: June 23, 2020

Date Posted: July 29, 2020

Recall Number: Z-2686-2020

Event ID: 86028

Reason for Recall:

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.

Status: Terminated

Product Quantity: 8 units

Code Information:

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

Distribution Pattern:

MO, NJ, OK, FL, OH, DC, Netherlands

Voluntary or Mandated:

Voluntary: Firm initiated