BEUDAMED
    FDA Enforcement Class I Ongoing

    Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.

    Recall: Z-1726-2025 · Reported May 21, 2025

    Enforcement

    Recall Number
    Z-1726-2025
    Event ID
    96611
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 21, 2025
    Initiation Date
    April 7, 2025
    Classification Date
    May 9, 2025
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.

    Reason

    A cybersecurity vulnerability was discovered through internal testing.

    Code Info

    ALL SERIAL NUMBERS: 1) BT-80-0004, UDI/DI 00887761978041 or 00815410020292 or 00887761978072; 2) BT-80-0004A, UDI/DI 00887761978041 or 00815410020292 or 00887761978072; 3) BT-80-0008, UDI/DI 00887761976283; 4) BT-80-0008A, UDI/DI 00887761976283; 5) RMS010093CP, UDI/DI 00887761978041 or 00815410020537 or 00815410020292.

    Distribution

    Worldwide distribution.

    Quantity

    4174 units