Terumo CDI OneView Monitor Probe May Fail to Display Oxygen Saturation Data
Terumo's CDI OneView Hematocrit/Oxygen Saturation Probe may intermittently fail to display oxygen saturation values during clinical use. When this occurs, the monitor displays dashes and triggers a yellow low-limit alarm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall where a patient monitoring probe may fail to display critical oxygen saturation data during clinical use. No injuries or deaths reported. This qualifies as a risk-of-harm product (patient monitoring equipment) where the monitoring failure could delay recognition of dangerous patient changes, but injury has not yet occurred.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe (Catalog Number REF CD1754). The probe is used to measure patient hematocrit and oxygen saturation levels during clinical care.
During clinical use, the probe may periodically fail to display the oxygen saturation (SO2) value. When this occurs, the monitor displays dashes to indicate unavailable data. The system also triggers a yellow low-limit alarm alerting clinicians to the data unavailability.
The recall affects 37 units distributed to healthcare facilities in Illinois, Texas, New York, Michigan, Florida, Nevada, and internationally in Australia and New Zealand. Affected units have serial numbers in the range H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, and H0050140-H0050142 (UDI/DI 00886799001882).
Clinicians using affected probes should contact Terumo Cardiovascular Systems Corporation for guidance on remediation or replacement.
The recalled product
- Product
- Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 37
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- UDI/DI 00886799001882
- Serial Number range: H0050095-H0050110
- H0050112-H0050116
- H0050118-H0050124
- H0050126
- H0050131-H0050134
- H0050136
- H0050140-H0050142
Distribution
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