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Tc-i reusable tip clip sensors
Official notice
7 Sept 2023
Last checked
7 Sept 2023
An official Health Canada notice concerns Tc-i reusable tip clip sensors. 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 Published 2023-09-07.
What to do now
Customer to contact Masimo to arrange return and replacement of affected devices.
Recall number
74240
Official notice
2023-09-07
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Masimo, Tc-i Reusable Tip Clip Sensors.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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