BEUDAMED
    FDA Recall Terminated

    Brilliance iCT Heavyweight Gantry Scanner, M/N 728306, S/N: 100016, 100018 -100025 The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    Recall: Z-2460-2010 · Initiated April 14, 2010

    Recall

    Recall Number
    Z-2460-2010
    Event Number
    56506
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 14, 2010
    Posted
    September 22, 2010
    Terminated
    September 24, 2012
    Address
    595 Miner Road, Cleveland, OH, 44143-2131

    Description

    Brilliance iCT Heavyweight Gantry Scanner, M/N 728306, S/N: 100016, 100018 -100025 The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    Reason

    The gantry covers of the iCT have a latch at the base of the system which holds the cover in the closed position. During the course of maintenance the CT Field Service Engineer (FSE) will activate this latching mechanism which in turn has a potential to penetrate the insulation on cabling which carries 277 VAC. If the latch does come into contact with the cabling there is a potential that the FS

    Action

    Philips Healthcare sent an URGENT - Field Safety Notice letter, dated April 14, 2010, to their customers notifying them of the product, the problem, and the action to be taken. The letter asked them to identify the affected product by checking for the serial number tag (s/n 10016 10025), ensure that the electrical power was shut-down before opening or closing the gantry cover to prevent potential of an electrical shock, and that a Field Service Engineer would contact the facility to make arrangements for the implementation of a Field Change Order (FCO) before December to correct the problem. For further information or support concerning this issue, the customer was instructed to contact their Philips representative: Customer Care Center (1-800-722-9377, option 5 or their local Philips Healthcare Office).

    Distribution

    Worldwide Distribution - USA, including the states: DC, GA, IL, IN, NY and OH; and the countries of Germany and the Netherlands.

    Quantity

    9 units