FDA-Device2025-04-09Class II
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Terumo Cardiovascular Systems Corporation
Hazard
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.
Sold states
US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
Affected count
37 units
Manufactured in
6200 Jackson Rd, Ann Arbor, MI, United States
Products
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1492-2025Don't want to check this manually?
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