BEUDAMED
    FDA Recall Terminated

    Mobile Diagnostic X-Ray System with Digital Panel

    Recall: Z-1706-2017 · Initiated November 28, 2012

    Recall

    Recall Number
    Z-1706-2017
    Event Number
    64902
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 28, 2012
    Terminated
    May 31, 2018
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Mobile Diagnostic X-Ray System with Digital Panel

    Reason

    When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.

    Action

    Philips Medicals Systems distributed an "URGENT Field Safety Notice" alerting customers of the defect on November 28, 2012. Customers are requested to manually rotate images by using the rotation tool.Customers are also recommended to check whether the automatic marker is set correctly, especially after a manual image rotation is performed. The marker can be corrected manually with the annotation tool.

    Distribution

    Nationwide (AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, MD, MI, MN, NC, NM, NY, OH, OR, PA, SC, TX, VT, WI)

    Quantity

    220 systems