BEUDAMED
    FDA Enforcement Class II Ongoing

    Luminos Agile Max (VE10, VF10, VF11)

    Recall: Z-1479-2023 · Reported May 31, 2023

    Enforcement

    Recall Number
    Z-1479-2023
    Event ID
    92229
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    May 31, 2023
    Initiation Date
    November 23, 2022
    Classification Date
    May 23, 2023
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Luminos Agile Max (VE10, VF10, VF11)

    Reason

    Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.

    Code Info

    Model: 10762472

    Distribution

    US Nationwide - Worldwide Distribution

    Quantity

    704 units in the United States (1945 units worldwide)