BEUDAMED
    FDA Recall Open, Classified

    Allura Xper IGTS Fixed Systems

    Recall: Z-0228-2024 · Initiated October 4, 2023

    Recall

    Recall Number
    Z-0228-2024
    Event Number
    93342
    Firm
    Philips North America
    FEI Number
    3006648320
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    October 4, 2023
    Posted
    September 30, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2296

    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.

    Distribution

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