BEUDAMED
    FDA Enforcement Class II Ongoing

    Zenition 50 & 70 Mobile Surgery C-arm

    Recall: Z-0226-2024 · Reported November 15, 2023

    Enforcement

    Recall Number
    Z-0226-2024
    Event ID
    93342
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 15, 2023
    Initiation Date
    October 4, 2023
    Classification Date
    November 9, 2023
    Address
    222 Jacobs St, Cambridge, MA, 02141-2296, United States

    Description

    Zenition 50 & 70 Mobile Surgery C-arm

    Reason

    Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

    Code Info

    Zenition 50 974 Zenition 50 1244 Zenition 50 1247 Zenition 50 892 Zenition 70 1735 Zenition 70 1824

    Distribution

    United States Territories of Puerto Rico, Guam, and Virgin Islands