BEUDAMED
    FDA Recall Open, Classified

    SIGNA Premier systems

    Recall: Z-1767-2026 · Initiated February 27, 2026

    Recall

    Recall Number
    Z-1767-2026
    Event Number
    98579
    Firm
    GE Healthcare LLC
    FEI Number
    3005326970
    Product Code
    LNH
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 27, 2026
    Posted
    April 2, 2026
    Address
    3001 W Radio Dr, Florence, SC, 29501-7806

    Description

    SIGNA Premier systems

    Reason

    Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.

    Action

    On 2/27/2026, correction notices were mailed to Director of Clinical/Radiology Risk Manager/Hospital Administrators informing them to take the following actions: 1) Ensure all potential servicing personnel in your facility are made aware of this safety notification and the recommended actions. 2) If the device requires service at the rear of the magnet, ensure that all servicing personnel are aware of this potential issue. 3) If servicing personnel have accessed the rear of the magnet with covers removed and identified that ferrous fittings are installed, do NOT attempt to remove or disconnect them. Call your GE HealthCare representative immediately. To help identify the parts: -The incorrect fittings (ferrous) are steel/silver in color -The correct fittings (non-ferrous) are brass/gold in color 4) Complete and return the acknowledgement form electronically via (https://gehealthcare-svc.my.site.com/publicForm/s/?formId=aGjUr000002kiJR) or print, fill out manually, scan and email to [email protected] If you have any questions or concerns regarding this notification, please contact the firm's HealthCare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, MA, NJ, NY, OH, SD, TX, VA, PR and the countries of Sweden, Switzerland, United Kingdom, Vietnam, China, Norway, Portugal, Spain, France, Germany, Greece, Korea, Republic of

    Quantity

    41