BEUDAMED
    FDA Recall Terminated

    Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85

    Recall: Z-1503-2014 · Initiated March 17, 2014

    Recall

    Recall Number
    Z-1503-2014
    Event Number
    67859
    Firm
    Philips Medical Systems, Inc.
    FEI Number
    1218950
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 17, 2014
    Posted
    April 24, 2014
    Terminated
    September 16, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85

    Reason

    The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held.

    Action

    On March 17, 2014, consignees were notified of the recall via letter. The letter explains what the issue is, actions firms can take to avoid or minimize the occurrence of the issue, and the actions planned by Philips to correct the issue. For further information or support concerning this issue, please contact your local Philips Representative. 1-800-722-9377

    Distribution

    Nationwide: US: AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WY / Worldwide including Canada & Mexico

    Quantity

    985 devices