BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1492-2025 · Initiated March 3, 2025

    Recall

    Recall Number
    Z-1492-2025
    Event Number
    96331
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DRY
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    March 3, 2025
    Posted
    March 31, 2025
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    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.

    Action

    Terumo Cardiovascular issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 03/03/2025 via email. The notice explained the reason for the removal, potential hazard, and requested the following: 1. Review this Medical Device Correction and assure that all users have received notice of this issue. 2. Confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. 3. Terumo CVS will contact users to discuss removal and correction activities. Note: Terumo CVS recommends that users continue using CDI OneView System H/S Probes while waiting for this removal

    Distribution

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

    Quantity

    37 units