FDA Device recall Z-1492-2025
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754 by Terumo Cardiovascular Systems, citing 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 yel….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1492-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-03 |
| Published | 2025-04-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | FL, IL, MI, NV, NY, TX |
Product
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Reason
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.
Identifiers
| code_info | UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Terumo Cardiovascular Systems
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FDA Device · Class II · 2025-07-02 · Terumo Cardiovascular Systems - Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66…
FDA Device · Class II · 2024-04-10 · Terumo Cardiovascular Systems - CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
FDA Device · Class II · 2023-04-12 · Terumo Cardiovascular Systems - CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
FDA Device · Class II · 2023-04-12 · Terumo Cardiovascular Systems - CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
FDA Device · Class II · 2023-04-12 · Terumo Cardiovascular Systems
All Terumo Cardiovascular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1492-2025%22
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