BEUDAMED
    FDA Enforcement Class II Ongoing

    Allura Xper IGTS Fixed Systems

    Recall: Z-0228-2024 · Reported November 15, 2023

    Enforcement

    Recall Number
    Z-0228-2024
    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

    Allura Xper IGTS Fixed Systems

    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

    Allura Xper FD10 285 Allura Xper FD10 1517 Allura Xper FD10 1634 Allura Xper FD10 177 Allura Xper FD10 764 ALLURA Xper FD10 C 249 Allura Xper FD20 2013 Allura Xper FD20 1334 Allura Xper FD20 1473 Allura Xper FD20 2110 Allura Xper FD20 2155 Allura Xper FD20 919 Allura Xper FD20 1581 Allura Xper FD20 2353 Allura Xper FD20 1811 Allura Xper FD20 2087 Allura Xper FD20 53364 Allura Xper FD20/15 172

    Distribution

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