BEUDAMED
    FDA Recall Terminated

    MEVION S250i, MEVION S250; Proton Radiation Treatment System

    Recall: Z-2406-2020 · Initiated May 15, 2020

    Recall

    Recall Number
    Z-2406-2020
    Event Number
    85748
    Firm
    Mevion Medical Systems, Inc.
    FEI Number
    3007087027
    Product Code
    LHN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 15, 2020
    Terminated
    December 11, 2020
    Address
    300 Foster St, Littleton, MA, 01460-2017

    Description

    MEVION S250i, MEVION S250; Proton Radiation Treatment System

    Reason

    Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off

    Action

    Mevion issued letter (pCAR0012) on May 15, 2020 via mail or FedEx, with return receipt confirmation. Letter states reason for recall, health risk and action to take: Until a software fix is applied for this problem, the user is cautioned to carefully pay attention to the 3 indicators of Couch corrections. If they disagree with the intended moves the user may simply repeat the alignment step and the problem should clear. Required User Action When using multimodal imaging the user should always check the indicators for Couch Corrections before they are applied. This includes the Verity Couch Correction widget, the Verity dialog box the informs the user of the actions being sent to the Couch, and the In Room Monitor lower right panel that displays the moves before they are made. If these disagree with the intended moves, the user should back up a step and resend the corrections. Users must confirm positioning for every applied Couch correction that all intended moves are indicated and made.

    Distribution

    Distribution to US in MO, NJ, OH, OK, FL, and DC, and the Netherlands

    Quantity

    8 units