FDAApril 21, 2023device
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
TC-I tip clip sensor may produce readings outside the accuracy specification.
What to do
FDA enforcement status: Ongoing
Brands named
masimo
UPCs
00843997003230
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMasimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,2024-02-15
- FDAMasimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,2024-02-15
- FDAMasimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,2024-02-15
- FDAMasimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,2024-02-15
- FDAMasimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 18952023-04-21
- FDAMasimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 40532023-04-21
- FDAMasimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 17942023-04-21
- FDArainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check or continuous non-invas...2015-10-28
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