Home / Recalls / Mevion Medical Systems, Inc. / Z-2686-2020

Z-2686-2020 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
July 29, 2020
Initiation Date
June 23, 2020
Termination Date
December 9, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8 units

Product Description

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

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.

Distribution Pattern

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

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

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-0485-2021 Class II — MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: in (October 19, 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)