BEUDAMED
    FDA Recall Terminated

    Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273. Intended for the properly positioning of patients to perform dental procedures.

    Recall: Z-1325-2010 · Initiated February 24, 2010

    Recall

    Recall Number
    Z-1325-2010
    Event Number
    54719
    Firm
    Pelton & Crane Company
    FEI Number
    1017522
    Product Code
    KLC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 24, 2010
    Posted
    April 1, 2010
    Terminated
    October 28, 2010
    Address
    11727 Fruehauf Dr, Charlotte, NC, 28273

    Description

    Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273. Intended for the properly positioning of patients to perform dental procedures.

    Reason

    Magnetic headrests may affect patients with implantable pacemakers and defibrillators.

    Action

    Pelton & Crane Issued an "Urgent Field Safety Alert" notification dated February 24, 2010. Consignees were instructed of the affected product and informed of proper actions to take. For further information, contact Pelton & Crane at 1-704-588-2126.

    Distribution

    Worldwide Distribution -- United States, Australia, the Netherlands, Canada and Germany.

    Quantity

    Total: 498 chairs and 619 replacement upholstery spare parts