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Health Canada Medical devices

TC-I Reusable Tip Clip Sensors

Issued September 7, 2023
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
Hazard description
Performance
Product
Product name
TC-I Reusable Tip Clip Sensors
Reference
ID
RA-74240