BEUDAMED
    FDA Recall Terminated

    GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.

    Recall: Z-1231-2016 · Initiated December 16, 2015

    Recall

    Recall Number
    Z-1231-2016
    Event Number
    73364
    FEI Number
    2519904
    Product Code
    RCE
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    December 16, 2015
    Terminated
    October 14, 2016
    Address
    Rd, GE Inspection Technologies, LP 50 Industrial Park, Lewistown, PA, 17044-9312

    Description

    GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.

    Reason

    GE Inspection Technologies, LP ("GE") has discovered that certain of its cabinet x-ray systems may not fully comply with the Food and Drug Administration's (FDA) Cabinet X ray System performance standards, 21 C.F.R. 1020.40(c)(1)(i)

    Action

    GE Inspection Technologies Planned Action to bring into Compliance: 1. GE Inspection Technologies will use their updated adhesive procedure to install new brackets to the bottom left and right lead strips in the control door. The new procedure and brackets were developed in November 2013. 2. A second notification of customers with affected systems will be sent within 5 days of approval of this CAP. This notification will describe the repair above and propose that a GE technician visit each site and install the described repair. 3. Repairs will be completed within 120 days after approval of this CAP and will be made free of charge. For further questions, please call (717) 447-1278. ;

    Distribution

    US Distribution to the states of : TX, MD, MI, CA, TN, NH, NY, AL, NC, ID, MA, AZ, IN, FL, PA, NJ, WI, VA, MN, MD CO, GA, SC, OH and DC.

    Quantity

    55 US Distribution