TC-I Reusable Tip Clip Sensors
Brand(s)
Last updated
Summary
Product
TC-I Reusable Tip Clip Sensors
Issue
Medical devices - Performance
What to do
Customer to contact Masimo to arrange return and replacement of affected devices.
Audience
Healthcare
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Masimo Corporation
52 Discovery, Irvine, California, United States, 92618
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74240
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