TC-I Reusable Tip Clip Sensors
Brand(s)
Summary
Customer to contact Masimo to arrange return and replacement of affected devices.
Affected products
Affected Products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Tc-I Reusable Tip Clip Sensors (LNCS Oximetry Sensor) |
Contact manufacturer. |
1895 |
Tc-I Reusable Tip Clip Sensors (M-LNCS Reusable Sensors) |
Contact manufacturer. |
2503 |
Tc-I Reusable Tip Clip Sensors (RD Set TC-I (Oximetry Sensor)) |
Contact manufacturer. |
4053 |
Issue
Masimo identified TC-I Reusable Tip Clip Sensors with higher than expected variability in spO2 readings that are outside of the accuracy specification. Masimo's investigation found the TC-I sensors had higher variability with an overall arms of 4.4% compared to the specification of 3.5% arms.
Recall Start Date: June 15, 2023
Additional information
Details
Masimo Corporation
52 Discovery, Irvine, California, United States, 92618
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