BEUDAMED
    FDA Recall Terminated

    TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).

    Recall: Z-0341-2012 · Initiated September 27, 2011

    Recall

    Recall Number
    Z-0341-2012
    Event Number
    60153
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    LKD
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    September 27, 2011
    Posted
    December 1, 2011
    Terminated
    February 19, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1521

    Description

    TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).

    Reason

    Transcutaneous pCO2-electrodes were wrongly coded as: pO2 electrode on the hardware plug for the firm's TCM series monitors. This causes the monitor to interpret the electrode wrongly, causing it to fail all calibrations and never get ready for use.

    Action

    Radiometer contacted the affected U.S. customer and informed them of the recall via telephone on September 27, 2011. Radiometer requested the return of the affected product received from the firm. For questions call (440) 871-0463.

    Distribution

    Worldwide Distribution - USA (nationwide) in the state of San Diego, CA.

    Quantity

    4 units were distributed.