Terumo Cardiovascular Systems Corporation: Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754

Hazard

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.

Details from the source

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: US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand Quantity: 37 units Lot/code info: UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142

UPC codes

00886799001882

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.