Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
FDA Recall Z-1492-2025 · Posted 2025-03-31
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Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusOpen, Classified
Product CodeDRY
Date Initiated2025-03-03
Product Quantity37 units
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.
Firm Action
Terumo Cardiovascular issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 03/03/2025 via email. The notice explained the reason for the removal, potential hazard, and requested the following:
1. Review this Medical Device Correction and assure that all users have received notice of this issue.
2. Confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form.
3. Terumo CVS will contact users to discuss removal and correction activities.
Note: Terumo CVS recommends that users continue using CDI OneView System H/S Probes while waiting for this removal
Root Cause
Software design
Distribution Pattern
US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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