FDA recall Z-1492-2025

Terumo Cardiovascular Systems Corporation · Class II · device

Product

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

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

Key facts

Status: Ongoing
Initiation date: 2025-03-03
Report date: 2025-04-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Ann Arbor, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1492-2025