BEUDAMED
    FDA Enforcement Class II Ongoing

    Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754

    Recall: Z-1492-2025 · Reported April 9, 2025

    Enforcement

    Recall Number
    Z-1492-2025
    Event ID
    96331
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 9, 2025
    Initiation Date
    March 3, 2025
    Classification Date
    March 31, 2025
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586, United States

    Description

    Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754

    Reason

    During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.

    Code Info

    UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142

    Distribution

    US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand

    Quantity

    37 units