BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;

    Recall: Z-0719-2026 · Reported December 3, 2025

    Enforcement

    Recall Number
    Z-0719-2026
    Event ID
    97719
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 3, 2025
    Initiation Date
    October 2, 2025
    Classification Date
    November 26, 2025
    Address
    Veenpluis 4-6, N/A, Best, N/A, N/A, Netherlands

    Description

    Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;

    Reason

    The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model.

    Code Info

    Model Number: 722234;

    Distribution

    Domestic: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MD, MN, MO, NM, NY, OH, OK, PA, RI, TX, UT, VA, WA, WI, WV, WY; International: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Iraq, Italy, Japan, Netherlands, Norway, Philippines, Poland, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, Vietnam;

    Quantity

    172 units