BEUDAMED
    FDA Enforcement Class II Terminated

    Xoran MiniCAT X-ray imaging device

    Recall: Z-1210-2015 · Reported March 11, 2015

    Enforcement

    Recall Number
    Z-1210-2015
    Event ID
    69939
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Xoran Technologies, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2015
    Initiation Date
    September 8, 2014
    Classification Date
    March 2, 2015
    Termination Date
    February 2, 2016
    Address
    5210 S State Rd, N/A, Ann Arbor, MI, 48108-7936, United States

    Description

    Xoran MiniCAT X-ray imaging device

    Reason

    Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.

    Code Info

    S/N ENT00031 MiniCAT0020 MiniCAT00361 MiniCAT00358 MiniCAT00150 MiniCAT00310 ENT00006 ENT00055 ENT00059 MiniCAT00140 MiniCAT00305 ENT00014 MiniCAT00148 ENT00039 ENT00076 MiniCAT00409 MiniCAT00179 ENT00014 MiniCAT00215 MiniCAT00309 ENT00035 MiniCAT00158 MiniCAT00386 MiniCAT00202 MiniCAT00324 ENT00127 MiniCAT00352 MiniCAT00396 MiniCAT00194 ENT00080 MiniCAT00171 MiniCAT00244

    Distribution

    Nationwide Distribution

    Quantity

    432