Home / Recalls / Mevion Medical Systems, Inc. / Z-1122-2017

Z-1122-2017 Class II Terminated

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

FDA device recall Z-1122-2017 was initiated by Mevion Medical Systems, Inc. on December 16, 2016 and is designated Class II. Reason for recall: An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened The recall status is terminated (terminated April 13, 2017). Affected quantity: 2 units.

Recall Details

Product Type
Devices
Report Date
February 8, 2017
Initiation Date
December 16, 2016
Termination Date
April 13, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

Product Description

MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy

Reason for Recall

An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened

Distribution Pattern

US Nationwide in the states of OK, NJ

Code Information

S250-0002 and S250-0003

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-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