Mevion Medical Systems, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0485-2021)

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 Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation

Product Classification:

Class II

Date Initiated: October 19, 2020

Date Posted: December 2, 2020

Recall Number: Z-0485-2021

Event ID: 86693

Reason for Recall:

Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur

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:

Worldwide distribution - US Nationwide distribution including in the states of DC, FL, MO, NJ, OK and the country of Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated