BEUDAMED
    FDA Enforcement Class II Ongoing

    Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006

    Recall: Z-2672-2025 · Reported October 8, 2025

    Enforcement

    Recall Number
    Z-2672-2025
    Event ID
    97451
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Schiller, Ag
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 8, 2025
    Initiation Date
    August 8, 2025
    Classification Date
    September 29, 2025
    Address
    Altgasse 68, N/A, Baar, N/A, N/A, Switzerland

    Description

    Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006

    Reason

    Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.

    Code Info

    REF: 1A.701307: UDI- 07613365003024 REF: 3.921002, UDI: 07613365001914 REF: 3.921030, UDI: 07613365003468 REF: 3.921031: UDI: 07613365003475 REF: 3.921006, UDI: 07613365000115 Affected Serial Numbers: 7010.000160 and lower, 7012.000356 and lower, 7013.000256 and lower, 7014.000152 and lower

    Distribution

    US Nationwide distribution in the states of MT, WI, IL.

    Quantity

    266 units