BEUDAMED
    FDA Recall Terminated

    Philips Healthcare System X-ray Tomography Computed :

    Recall: Z-0376-2017 · Initiated March 15, 2016

    Recall

    Recall Number
    Z-0376-2017
    Event Number
    75551
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    March 15, 2016
    Terminated
    September 9, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips Healthcare System X-ray Tomography Computed :

    Reason

    It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.

    Action

    Philips planned action: 1. Philips issued a customer notification letter on October 13, 2016. The letter includes a statement that the corrections will be made free of charge. 2. Philips will initiate a field corrective action to address the issue. 3. Philips will contact the customer and schedule an inspection to determine if the unit requires repair. 4. If repair is required, the couch horizontal linkage assembly will be replaced. For further questions please call (978) 659-3000.

    Distribution

    USA(nationwide) Distribution to the states of : AZ, NY, GA, UT, TN, TX, AR, NV, Il, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL and IA.

    Quantity

    1363