BEUDAMED
    FDA Enforcement Class II Ongoing

    Intelli-C, Right side suspended Tabletop, REF: 03400000

    Recall: Z-1668-2023 · Reported June 7, 2023

    Enforcement

    Recall Number
    Z-1668-2023
    Event ID
    92230
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    NRT X-RAY A/S
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 7, 2023
    Initiation Date
    April 27, 2023
    Classification Date
    May 31, 2023
    Address
    Birkegardsvej 16, N/A, Hasselager, N/A, N/A, Denmark

    Description

    Intelli-C, Right side suspended Tabletop, REF: 03400000

    Reason

    There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.

    Code Info

    UDI-DI: 05713464000527/Serial Numbers: 627004, 627007, 639001, 639002,639003, 639004, 639007, 639010, 647001, 647004, 647005, 648001, 651007, 658002, 658003, 658006, 658010, 666008, 675001, 675004, 682006, 682010

    Distribution

    US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY.

    Quantity

    32 units