FDAOctober 28, 2015device
rainbow 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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters.
What to do
FDA enforcement status: Terminated
Brands named
masimo
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 with temperature (W/Sensor), REF:9210, 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 LNOP TC-I SpO2, Reusable Ear Sensor, REF: 17942023-04-21
- FDAMasimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 40532023-04-21
- FDAMasimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 25032023-04-21
- FDAMasimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 18952023-04-21
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