Recall Z-1492-2025 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
| Date | Mar 31, 2025 (initiated Mar 3, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| 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 |
| Quantity | 37 units |
| Distribution | US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K234065 | CDI OneView Monitoring System Terumo Cardiovascular Systems Corporation, Apr 25, 2024 |