Class II

Medical Device Recall: Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754

Terumo Cardiovascular Systems Corporation · March 3, 2025

Reason for Recall

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.

Distribution

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

States Affected

FL, IL, MI, NV, NY, TX

Quantity Affected

37 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1492-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Terumo Cardiovascular Systems Corporation Medical Device Recall: Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754 | SafeCheck