BEUDAMED
    FDA Enforcement Class II Ongoing

    Surpria: Software Version V3.11, V3.22

    Recall: Z-1749-2022 · Reported September 21, 2022

    Enforcement

    Recall Number
    Z-1749-2022
    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: 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)04580292766601(11)200130(21)W5067(250)G560045319 (01)04580292766601(11)200220(21)W5068(250)G560048119 (01)04580292766601(11)200902(21)W5069(250)G560071519 (01)04580292766601(11)201210(21)W5070(250)G560075519 (01)04580292766601(11)201225(21)W5071(250)G1Z0040620 (01)04580292766601(11)210218(21)W5072(250)G1Z0063520 (01)04580292766601(11)210512(21)W5073(250)G1Z0244920 (01)04580292766601(11)210519(21)W5074(250)G1Z0048121 (01)04573596200520(11)210818(21)W5075(250)G1Z0083221 (01)04573596200520(11)210903(21)W5076(250)G1Z0094621 (01)04573596200520(11)210903(21)W5077(250)G1Z0094521 (01)04573596200520(11)210903(21)W5077(250)G1Z0094521 (01)04573596200520(11)211018(21)W5079(250)G1Z0123621 (01)04573596200520(11)211115(21)W5080(250)G1Z0190221 (01)04573596200520(11)211122(21)W5081(250)G1Z0190021 (01)04573596200520(11)211122(21)W5082(250)G1Z0190121 (01)04573596200520(11)211227(21)W5083(250)G1Z0190321 (01)04573596200520(11)211228(21)W5084(250)G1Z0210821 (01)04573596200520(11)220209(21)W5085(250)G1Z0210921 (01)04573596200520(11)220215(21)W5086(250)G1Z0211021 Serial Numbers: G560045319 G560048119 G560071519 G560075519 G1Z0040620 G1Z0063520 G1Z0244920 G1Z0048121 G1Z0083221 G1Z0094621 G1Z0094521 G1Z0115321 G1Z0123621 G1Z0190221 G1Z0190021 G1Z0190121 G1Z0190321 G1Z0210821 G1Z0210921 G1Z0211021

    Distribution

    US Nationwide Distribution

    Quantity

    20 units