BEUDAMED
    FDA Recall Terminated

    Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: 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. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    Recall: Z-0307-2019 · Initiated June 7, 2017

    Recall

    Recall Number
    Z-0307-2019
    Event Number
    81403
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 7, 2017
    Terminated
    July 3, 2019
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: 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. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    Reason

    It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.

    Action

    The recalling firm sent Customer Information letters dated June 7, 2017, to affected customers. The letter notified customers of the product issue. Customers were instructed to determine whether they had a potentially affected system by checking the software version of their device. Customers were reminded that the "Impressions" section of the report is not intended for diagnostic use. Users should instead focus on the total calcium score shown in the "Findings" section, the coronary artery score(s) and/or the "Age and Gender" graph as identified in the Instructions for Use (IFU). The firm sent a follow-up dated July 3, 2018, to inform customers that software updates had been released which resolved the issue. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America and Canada, contact the Customer Care Solutions Center (1 -800-722-9377 and follow the prompts).

    Distribution

    US Nationwide Distribution

    Quantity

    145