BEUDAMED
    FDA Enforcement Class II Terminated

    Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.

    Recall: Z-1727-2020 · Reported June 3, 2020

    Enforcement

    Recall Number
    Z-1727-2020
    Event ID
    85498
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nikon Metrology
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 3, 2020
    Initiation Date
    December 23, 2019
    Classification Date
    May 22, 2020
    Termination Date
    June 13, 2024
    Address
    12701 Grand River Rd, N/A, Brighton, MI, 48116, United States

    Description

    Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.

    Reason

    The manufacturer identified a risk that their products might fail to comply with the cabinet x-ray system performance standard limit on x-ray emissions [21 CFR 1020.40(c)(1)] due to an insufficient safety margin for the means of attachment of a piece of interior x-ray shielding. Double sided industrial tape was used for attachment - there have been only 2 instances of detachment and although the piece of shielding detached it remained mostly in place supported by wires that pass through that piece of shielding. The repair is accomplished by adding a bracket to fasten the piece of shielding securely to the inside of the x-ray system. Mfr reports that no systems were found to have exceeded the emission limit when checked prior to repair.

    Code Info

    all STH225, XTH225ST, and MCT225 units)

    Distribution

    US Nationwide Distribution

    Quantity

    110 units