Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1492-2025 — Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754

U.S. FDA — Device Enforcement · United States · 2025-03-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1492-2025
Date of alert
2025-03-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Terumo Cardiovascular Systems Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00886799001882
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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