BEUDAMED
    FDA Recall Terminated

    Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse CoOximeter

    Recall: Z-0661-06 · Initiated February 2, 2006

    Recall

    Recall Number
    Z-0661-06
    Event Number
    34569
    Firm
    Masimo Corporation
    FEI Number
    3001452206
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 2, 2006
    Posted
    March 18, 2006
    Terminated
    June 17, 2008
    Address
    40 Parker, Irvine, CA, 92618-1604

    Description

    Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse CoOximeter

    Reason

    Internal testing revealed that some of the sensors might not meet the accuracy specifications of : 2% for SpO2 and of: 3% for SpCO, due to the tolerance of one of the emitter LED's used in the calculation ofSpO2 and SpCO. The SpO2 reading may have a negative bias of up to 1 % and the SpCO reading may have a negative bias of up to 4%.

    Action

    Masimo notified all customers by letter sent via Federal Express who were shipped Rainbow DC- I-DC sensors to return them to Masimo for repair or replacement. A Tracking/Verification form will be mailed with the letter to be faxed back to Masimo. Masimo will repair or replace the returned units and return them back to the customer.

    Distribution

    Nationwide and Belgium, Canada, France, Germany, Italy, South Korea, new Zealand, Slovenia, Spain, Sweden, Switzerland, and United Arab Emirates

    Quantity

    321