BEUDAMED
    FDA Recall Open, Classified

    Luminos Agile Max (VE10, VF10, VF11)

    Recall: Z-1479-2023 · Initiated November 23, 2022

    Recall

    Recall Number
    Z-1479-2023
    Event Number
    92229
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    November 23, 2022
    Posted
    May 23, 2023
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    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.

    Action

    Siemens Medical Solutions USA, Inc., will provide software updates to the affected systems with software versions VF10 and VF11 with software via Update Instructions (UI) XP007/23/S, XP004/23/S, XP003/23/S, and XP001/23/S

    Distribution

    US Nationwide - Worldwide Distribution

    Quantity

    704 units in the United States (1945 units worldwide)