Health product recall

TC-I Reusable Tip Clip Sensors

Last updated

Summary

Product
TC-I Reusable Tip Clip Sensors
Issue
Medical devices - Performance issue
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