Home / Recalls / Mevion Medical Systems, Inc. / Z-0411-2017

Z-0411-2017 Class II Terminated

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

FDA device recall Z-0411-2017 was initiated by Mevion Medical Systems, Inc. on October 20, 2016 and is designated Class II. Reason for recall: Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of… The recall status is terminated (terminated May 15, 2017). Affected quantity: 6 units.

Recall Details

Product Type
Devices
Report Date
November 23, 2016
Initiation Date
October 20, 2016
Termination Date
May 15, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 units

Product Description

MEVION S250 Product Usage: Proton Radiation Therapy System

Reason for Recall

Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter

Distribution Pattern

US Nationwide Distribution in the states of: FL, MO, NJ, OH, OK

Code Information

Serial Numbers: S250-0001 through S250-0006

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-1529-2016 Class II — MEVION S250 for Proton Radiation Therapy (March 15, 2016)

FDA data resources