BEUDAMED
    FDA Enforcement Class II Terminated

    GE Inspection Technologies Blade|line Industrial Cabinet X-ray system

    Recall: Z-2777-2017 · Reported August 9, 2017

    Enforcement

    Recall Number
    Z-2777-2017
    Event ID
    77756
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Inspection Technologies, LP
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    August 9, 2017
    Initiation Date
    June 28, 2017
    Classification Date
    August 1, 2017
    Termination Date
    February 6, 2020
    Address
    50 Industrial Park Rd, N/A, Lewistown, PA, 17044-9312, United States

    Description

    GE Inspection Technologies Blade|line Industrial Cabinet X-ray system

    Reason

    GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliRoentgen in one hour (21 CFR ¿ 1020.40(c)(1)(i)) underneath the bottom center of the system. The crawl space affected by the excess emission is approximately 22 inches high, normally covered by decorative panels, and is not intended to be accessed.

    Code Info

    Serial No. TM 201317 TM 201312 TM 201323 TM 201331 TM 201401 TM 201329 TM 201404 TM 201413 TM 201414 TM 201415 TM 201424 TM 201425 158017R1

    Distribution

    US Distribution to the states of : AL, SC, OH, MI, PA, and Internationally to Germany and Singapore

    Quantity

    13 units distributed in the US