BEUDAMED
    FDA Recall Open, Classified

    Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D

    Recall: Z-1144-2023 · Initiated January 16, 2023

    Recall

    Recall Number
    Z-1144-2023
    Event Number
    91415
    Firm
    Hologic, Inc.
    FEI Number
    1220984
    Product Code
    OTE
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    January 16, 2023
    Posted
    February 21, 2023
    Address
    36 Apple Ridge Rd, Danbury, CT, 06810-7301

    Description

    Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D

    Reason

    C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual

    Action

    Hologic issued Urgent Medical Device Correction Letter customized to the customer on 01/16/23. Letter states reason for recall, health risk and action to take: We will schedule a service appointment and dispatch a field service engineer to visit your site to inspect your system and if necessary, make any corrections. " This will take approximately 6-14 hours to complete. " Until your service appointment, you will be able to continue to use your Selenia Dimensions or 3Dimensions system. If at any time during system operation, you observe any unanticipated error messages, or unexpected Carm movement, please discontinue use and contact Hologic's Technical Support immediately. Additionally, if you have any questions, please do not hesitate to reach out to Hologic's Technical Support at 1-877-371-4372 or [email protected]. Complete the on line Customer Confirmation Form using the link below within 3 business days of receiving this notice. Replying promptly will confirm your receipt of the notification and prevent you from receiving repeat notices. www.novasyte.com/hologic/selenia-dimensions-2022

    Distribution

    US Nationwide distribution.

    Quantity

    797 units