BEUDAMED
    FDA Recall Terminated

    BrightView XCT , Model Number 882482

    Recall: Z-2011-2019 · Initiated June 10, 2019

    Recall

    Recall Number
    Z-2011-2019
    Event Number
    83201
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 10, 2019
    Terminated
    July 24, 2020
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    BrightView XCT , Model Number 882482

    Reason

    An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.

    Action

    Urgent Field Safety Notice Medical Device Correction letters dated 6/4/19 were sent to customers. Discontinue Use of the BrightView Handcontroller. Remove the handcontroller from the charging station and store in a secure location inaccessible by technicians, at least 20 meters (65 feet) away from the system and outside the imaging room. If 20 meters (65 feet) is not possible, then store the handcontroller in an area that is shielded, such as a hot lab. Do not dispose of the hand controller, as it will be needed once a solution is identified. Instead of the physical handcontroller, use the virtual handcontroller located on the touchscreen monitor attached to the gantry as shown in Figure 3. Philips Healthcare is distributing this FSN to all affected customers/users and will deploy a technical solution addressing the issue upon completion of the investigation. If you need any further information or support concerning this issue, please contact your local Philips representative: For SUPPORT in North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    427