BEUDAMED
    FDA Enforcement Class II Terminated

    Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050

    Recall: Z-0365-2016 · Reported December 9, 2015

    Enforcement

    Recall Number
    Z-0365-2016
    Event ID
    69090
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 9, 2015
    Initiation Date
    August 19, 2014
    Classification Date
    December 3, 2015
    Termination Date
    June 14, 2016
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050

    Reason

    The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.

    Code Info

    All patient support for stitching are affected.

    Distribution

    Distributed in the states of MN, KY, MA, VA, TX, NC, HI, FL, AZ, CT, and WY and the countries of Argentina, Australia, Austria, Canada, Denmark, Germany, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and Switzerland.

    Quantity

    260 units, not all units have the patient support accessory