Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
FDA device recall Z-1492-2025 · posted 2025-03-31 · Open, Classified
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- DRY
- Quantity affected
- 37 units
- Distribution
- US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
- Date initiated
- 2025-03-03
- Date posted
- 2025-03-31
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CDI OneView Monitoring System (K234065) | Terumo Cardiovascular Systems Corporation | 2024-04-25 |