BEUDAMED
    FDA Enforcement Class II Ongoing

    Surpria 64: Software Version V3.11, V3.22

    Recall: Z-1750-2022 · Reported September 21, 2022

    Enforcement

    Recall Number
    Z-1750-2022
    Event ID
    90751
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    FUJIFILM Healthcare Americas Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 21, 2022
    Initiation Date
    July 12, 2022
    Classification Date
    September 15, 2022
    Address
    81 Hartwell Ave Ste 300, Lexington, MA, 02421-3160, United States

    Description

    Surpria 64: Software Version V3.11, V3.22

    Reason

    Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation

    Code Info

    UDI: (01)04573596200520(11)220215(21)W5086(250)G1Z0211021 (01)04580292766601(11)200130(21)W8013(250)G1Z0098019 (01)04580292766601(11)200226(21)W8014(250)G1Z0130719 (01)04580292766601(11)201217(21)W8015(250)G1Z0024020 (01)04580292766601(11)210217(21)W8016(250)G1Z0216720 (01)04580292766601(11)210528(21)W8017(250)G1Z0239620 (01)04580292766601(11)210610(21)W8018(250)G1Z0039321 (01)04580292766601(11)210628(21)W8019(250)G1Z0223420 (01)04573596200520(11)210727(21)W8020(250)G1Z0087821 (01)04573596200520(11)210825(21)W8021(250)G1Z0139021 (01)04573596200520(11)211012(21)W8022(250)G1Z0112721 (01)04573596200520(11)211026(21)W8023(250)G1Z0156921 (01)04573596200520(11)220113(21)W8024(250)G1Z0043121 (01)04573596200520(11)220113(21)W8025(250)G1Z0240221 (01)04573596200520(11)220204(21)W8026(250)G1Z0244021 (01)04573596200520(11)220204(21)W8027(250)G1Z0249821 (01)04573596200520(11)220214(21)W8028(250)G1Z0249921 Serial Numbers: G1Z0098019 G1Z0130719 G1Z0024020 G1Z0216720 G1Z0239620 G1Z0039321 G1Z0223420 G1Z0087821 G1Z0139021 G1Z0112721 G1Z0156921 G1Z0043121 G1Z0240221 G1Z0244021 G1Z0249821 G1Z0249921

    Distribution

    US Nationwide Distribution

    Quantity

    16 units