BEUDAMED
    FDA Recall Open, Classified

    Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)

    Recall: Z-2471-2020 · Initiated May 22, 2020

    Recall

    Recall Number
    Z-2471-2020
    Event Number
    85793
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    FEI Number
    1000513161
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    May 22, 2020
    Address
    81 Hartwell Ave, Ste 300, Lexington, MA, 02421-3160

    Description

    Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)

    Reason

    Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in misdiagnosis

    Action

    Fujifilm issued URGENT: Medical Device Correction and Removal notification via FedEx standard overnight mail on May 22, 2020, stating reason for recall, health risk and action to take: recommending that you do not perform Tomosynthesis on these views until the correction is applied. FUJIFILM is providing hotfixes for Synapse PACS Versions 5.5, 5.7.0, and 5.7.1 to resolve these issues. Please contact Customer Service at 1-888-FUJIMED (1-888-385-4633). Cmplete and return the Field Action Verification Form Providing the response with the information requested is essential for ensuring appropriate action is taken. Contact field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email at [email protected], if you have any further questions regarding this field action.

    Distribution

    Nationwide

    Quantity

    135 units