FDAMarch 3, 2025device
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
terumo cardiovascular systemsterumoterumo cardiovascular
UPCs
00886799001882
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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