Z-1492-2025 Class II Ongoing
FDA device recall Z-1492-2025 was initiated by Terumo Cardiovascular Systems Corporation on March 3, 2025 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 37 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 9, 2025
- Initiation Date
- March 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37 units
Product Description
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
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.
Distribution Pattern
US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
Code Information
UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142