PlainRecalls
FDA Devices Moderate Class II Terminated

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-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate.

Reported: December 2, 2015 Initiated: October 28, 2015 #Z-0338-2016

Product Description

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-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate.

Reason for Recall

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.

Details

Recalling Firm
Masimo Corporation
Units Affected
3476 units total (3322 units in US)
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Australia, Costa Rica, France, Germany, Kuwait, Martinique, Netherlands, Norway, South Korea, and Turkey.
Location
Irvine, CA

Frequently Asked Questions

What product was recalled? ▼
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-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate.. Recalled by Masimo Corporation. Units affected: 3476 units total (3322 units in US).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 2, 2015. Severity: Moderate. Recall number: Z-0338-2016.

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