Home / Recalls / Mevion Medical Systems, Inc. / Z-0485-2021

Z-0485-2021 Class II Terminated

Recalled by Mevion Medical Systems, Inc. — Littleton, MA

Recall Details

Product Type
Devices
Report Date
December 2, 2020
Initiation Date
October 19, 2020
Termination Date
August 31, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8 units

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

Reason for Recall

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

Distribution Pattern

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

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

Other recalls by Mevion Medical Systems, Inc.

  • Z-0827-2022 Class II — Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 3780 (February 1, 2022)
  • Z-2686-2020 Class II — MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiat (June 23, 2020)
  • Z-2406-2020 Class II — MEVION S250i, MEVION S250; Proton Radiation Treatment System (May 15, 2020)
  • Z-0705-2019 Class II — MEVION S250i (October 1, 2018)
  • Z-2746-2018 Class II — MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage (June 29, 2018)
  • Z-1122-2017 Class II — MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy (December 16, 2016)
  • Z-0409-2017 Class II — MEVION S250 Product Usage: Proton Radiation Therapy (October 31, 2016)
  • Z-0410-2017 Class II — MEVION S250 Product Usage: Proton Radiation Therapy System (October 21, 2016)
  • Z-0411-2017 Class II — MEVION S250 Product Usage: Proton Radiation Therapy System (October 20, 2016)
  • Z-1529-2016 Class II — MEVION S250 for Proton Radiation Therapy (March 15, 2016)