BEUDAMED
    FDA Recall Open, Classified

    GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8) To be provided.

    Recall: Z-0813-2025 · Initiated November 25, 2024

    Recall

    Recall Number
    Z-0813-2025
    Event Number
    95958
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    IZL
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    November 25, 2024
    Posted
    January 7, 2025
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8) To be provided.

    Reason

    GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.

    Action

    GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 11/25/2024 via letter issued using traceable means. The notice explained the issue, safety issue, and requested the following actions be taken by the user: "1. Perform a check of your device prior to each patient exam to look for the following behaviors. If any are observed, DO NOT use the device and call GE HealthCare Service Immediately. . Column vertical movement requires increased effort. . Column has change in resistance (i.e. movement is not smooth) during vertical movement. . Column makes abnormal noises during vertical movement. 2. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. 3. Please retain this document for your records. 4. Please complete and return the attached acknowledgement form to [email protected]" For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. On 02/11/2025, the firm send an updated notice with a corrected GTIN for Optima XR200amx.

    Distribution

    Worldwide

    Quantity

    120 units