Z-0338-2016 Class II Terminated
FDA device recall Z-0338-2016 was initiated by Masimo Corporation on October 28, 2015 and is designated Class II. 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. The recall status is terminated (terminated May 18, 2016). Affected quantity: 3476 units total (3322 units in US).
Recall Details
- Product Type
- Devices
- Report Date
- December 2, 2015
- Initiation Date
- October 28, 2015
- Termination Date
- May 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3476 units total (3322 units in US)
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.
Distribution Pattern
Worldwide Distribution - US (nationwide) and Internationally to Australia, Costa Rica, France, Germany, Kuwait, Martinique, Netherlands, Norway, South Korea, and Turkey.
Code Information
2201 2407 2696 2697