BEUDAMED
    FDA Recall Terminated

    Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems 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-0832-2014 · Initiated December 9, 2013

    Recall

    Recall Number
    Z-0832-2014
    Event Number
    67306
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 9, 2013
    Posted
    January 27, 2014
    Terminated
    May 29, 2014
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems 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

    Patient images exhibited ring artifacts.

    Action

    The firm, Philips Healthcare, sent an "URGENT - Medical Device Correction" letter dated December 9, 2013 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following to avoid the occurrence of these specific ring artifacts: 1. Disable Automatic Scan Time for all Exam Cards 2. Leave Automatic Scan Time on during planning and prior to clicking Go to initiate the scan, click the acquisition series of the scan and disable Automatic Scan Time, then proceed with the scan. 3. Disable Edit Before Final Recon (Reconstruction) for all Exam Cards If a ring artifact is present, clinical judgment should be used by the customer/user to determine if the images acquired in the dataset contain enough information to make a diagnosis. Philips will be releasing a Field Change Order (FCO) to correct the issue with software version release 4.1.1.19261. In addition, a Philips Field Service Engineer will contact you to schedule the software installation at your site. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts).

    Distribution

    Worldwide Distribution: US (nationwide) including states of: FL, IN, NY, OR and PA; and internationally to: Australia and Israel.

    Quantity

    7 units