Home / Recalls / Mevion Medical Systems, Inc. / Z-0705-2019

Z-0705-2019 Class II Terminated

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

FDA device recall Z-0705-2019 was initiated by Mevion Medical Systems, Inc. on October 1, 2018 and is designated Class II. Reason for recall: Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped The recall status is terminated (terminated April 10, 2020). Affected quantity: 1 unit.

Recall Details

Product Type
Devices
Report Date
January 16, 2019
Initiation Date
October 1, 2018
Termination Date
April 10, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

MEVION S250i

Reason for Recall

Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped

Distribution Pattern

DC

Code Information

DI: (01)00864366000124 Serial Number: S250i-0007

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-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-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)

FDA data resources