BEUDAMED
    FDA Recall 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.

    Recall: Z-0338-2016 · Initiated October 28, 2015

    Recall

    Recall Number
    Z-0338-2016
    Event Number
    72626
    Firm
    Masimo Corporation Forty Parker
    FEI Number
    3001452206
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Finished device change control
    Initiated
    October 28, 2015
    Posted
    November 25, 2015
    Terminated
    May 18, 2016
    Address
    Irvine, CA, 92618

    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

    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.

    Action

    Masimo sent an Urgent Product Recall letter on October 28, 2015, to all affected customers to inform them that Masimo has identified specific lots of sensors that were manufactured with incompatiable configurations. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to complete the tracking/verification form and email to Masimo. Customers with questions were instructed to contact Masimo Technical Services at http://Service.Masimo.com. For questions regarding this recall call 949-297-7000.

    Distribution

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

    Quantity

    3476 units total (3322 units in US)