BEUDAMED
    FDA Recall Open, Classified

    CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwristregionsatthedirectionofhealthcareprofessionalsasdiagnosticsupportforpediatricandadultpatients.

    Recall: Z-1627-2023 · Initiated July 21, 2021

    Recall

    Recall Number
    Z-1627-2023
    Event Number
    92206
    Firm
    Trophy SAS Trophy Sas Trophy; Croissy Beaubourg
    FEI Number
    7695
    Product Code
    OAS
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    July 21, 2021
    Posted
    May 27, 2023
    Address
    4 Rue Pelloutier Marne La Vallee Cedex 2 France

    Description

    CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwristregionsatthedirectionofhealthcareprofessionalsasdiagnosticsupportforpediatricandadultpatients.

    Reason

    Device failed to function as intended and/or failed to conform to their design specifications.

    Action

    The letter identified the affected product, problem and actions to be taken.

    Distribution

    Worldwide Distribution

    Quantity

    895 units