BEUDAMED
    FDA Enforcement Class II Ongoing

    BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.

    Recall: Z-0224-2024 · Reported November 15, 2023

    Enforcement

    Recall Number
    Z-0224-2024
    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

    BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm 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

    Endura 2.2 1195 Endura 2.2 1202 Endura 2/3 95 Endura 2/3 429 Endura 2/3 443 Endura 2/3 868 Endura 2/3 871 Endura 2/3 998 Endura 2/3 1231 Pulsera 2.2 1623 Pulsera 2.2 1731 Pulsera 2.2 2501 Pulsera 2.2 2507 Pulsera 2.2 641 Pulsera 2.2 884 Pulsera 2.2 882 Pulsera 2.2 1483 Pulsera 2.2 883 Pulsera 2.2 1711 Pulsera 2.3 234 Pulsera 2.3 454 Pulsera 2.3 547 Pulsera 2.3 546 Pulsera 2.3 1044 Pulsera 2.3 1205 Pulsera 2.3 1774 Pulsera 2.3 2709 Pulsera 2.3 3880 Pulsera 2.3 13817 Pulsera 2.3 13818

    Distribution

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