Home / Recalls / Mevion Medical Systems, Inc. / Z-1529-2016

Z-1529-2016 Class II Terminated

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

FDA device recall Z-1529-2016 was initiated by Mevion Medical Systems, Inc. on March 15, 2016 and is designated Class II. Reason for recall: Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury … The recall status is terminated (terminated August 24, 2017). Affected quantity: 5.

Recall Details

Product Type
Devices
Report Date
April 27, 2016
Initiation Date
March 15, 2016
Termination Date
August 24, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5

Product Description

MEVION S250 for Proton Radiation Therapy

Reason for Recall

Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or death.

Distribution Pattern

US nationwide distribution to MO, OK, FL, and NJ.

Code Information

S250-0002

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