BEUDAMED
    FDA Enforcement Class II Ongoing

    Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.

    Recall: Z-1583-2025 · Reported April 30, 2025

    Enforcement

    Recall Number
    Z-1583-2025
    Event ID
    96598
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Medical Systems Nederland B.V.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    April 30, 2025
    Initiation Date
    July 20, 2023
    Classification Date
    April 21, 2025
    Address
    High Tech Campus 36, N/A, Eindhoven, N/A, N/A, Netherlands

    Description

    Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.

    Reason

    Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.

    Code Info

    Zenition 70

    Distribution

    US Nationwide distribution

    Quantity

    12 systems