Masimo identified TC- I reusable tip clip sensors with higher-than-expected variability in SpM2 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. These sensors are included with the BP-200 plus device with the SpO2 option. Recall start date: March 14, 2024
RecallTracker