BEUDAMED
    FDA Recall Open, Classified

    Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP

    Recall: Z-1590-2026 · Initiated February 3, 2026

    Recall

    Recall Number
    Z-1590-2026
    Event Number
    98447
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    February 3, 2026
    Posted
    March 20, 2026
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP

    Reason

    There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.

    Action

    An URGENT MEDICAL DEVICE CORRECTION notification letter dated 2/3/26 was sent to customers. Actions to be taken by Customer / User You can continue to use your system if you DO NOT use needles with metal handles or metal hubs. A User Manual addendum is included with this letter (see Appendix A) that includes specific instructions to avoid the use of needles with metal handles or metal hubs. Please place a copy of the addendum in Appendix A with the User Manual for each Imactis CT Navigation" system in your facility. Please ensure all potential users in your facility are made aware of this safety notification and the required actions. Please retain this document for your records. Please complete and return the attached acknowledgement form to [email protected] or use the QR code to submit your response electronically. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    125 units