BEUDAMED
    FDA Enforcement Class II Ongoing

    RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00

    Recall: Z-1656-2026 · Reported April 8, 2026

    Enforcement

    Recall Number
    Z-1656-2026
    Event ID
    98518
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Reflexion Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    April 8, 2026
    Initiation Date
    February 9, 2026
    Classification Date
    March 27, 2026
    Address
    25881 Industrial Blvd, Hayward, CA, 94545-2991, United States

    Description

    RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00

    Reason

    Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.

    Code Info

    Software Version: 2.1.29-4 and Software Version: 2.1.35-1. UDI: (01)00860003983812(11)230504(21)X11001, (01)00860003983812(11)230518(21)X11002, (01)00860003983812(11)230505(21)X11003, (01)00860003983812(11)230530(21)X11004, (01)00860003983812(11)230811(21)X11006, (01)00860003983812(11)230410(21)X11007, (01)00860003983812(11)230803(21)X11008, (01)00860003983812(11)240528(21)X11009, (01)00860003983812(11)240820(21)X11010, (01)00860003983812(11)241107(21)X11011, (01)00860003983812(11)241206(21)X11012, (01)00860003983812(11)250731(21)X11013.

    Distribution

    US: CA, TX, PA, CT, NJ, OR, LA, OH

    Quantity

    12