Masimo Corporation: Medical Device Recall in 2015 - (Recall #: Z-0338-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 28, 2015

Date Posted: December 2, 2015

Recall Number: Z-0338-2016

Event ID: 72626

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.

Status: Terminated

Product Quantity: 3476 units total (3322 units in US)

Code Information:

2201 2407 2696 2697

Distribution Pattern:

Worldwide Distribution - US (nationwide) and Internationally to Australia, Costa Rica, France, Germany, Kuwait, Martinique, Netherlands, Norway, South Korea, and Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated