Home / Recalls / Mevion Medical Systems, Inc. / Z-0588-2015

Z-0588-2015 Class II Terminated

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

FDA device recall Z-0588-2015 was initiated by Mevion Medical Systems, Inc. on November 10, 2014 and is designated Class II. Reason for recall: Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in … The recall status is terminated (terminated March 18, 2015). Affected quantity: 1.

Recall Details

Product Type
Devices
Report Date
December 17, 2014
Initiation Date
November 10, 2014
Termination Date
March 18, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

MEVION S250, used for proton radiation therapy.

Reason for Recall

Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.

Distribution Pattern

US Distribution in the state of MO

Code Information

Serial Number: S250-0001

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-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)

FDA data resources