Reported Dec 2, 2015 · Terminated
rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No.…
Masimo Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Masimo Corporation · Forty Parker · Irvine, CA · 92618
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
2201 | rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet |
2407 | RAINBOW DCI-dc8, SpO2/SpCO/SpMet |
2696 | RAINBOW DCI, SpO2/SpCO/SpMet |
2697. | RAINBOW DCIP, PED, SpO2/SpCO/SpMet, rainbow reusable sensors are indicated for spot check or continuous non-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate. |
- Lot codes and dates
- 2201 2407 2696 2697
- Amount recalled
- 3476 units total (3322 units in US)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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