BEUDAMED
    FDA Recall Terminated

    Propaq LT vital signs monitor, Model 802LTRN

    Recall: Z-0216-2007 · Initiated October 22, 2006

    Recall

    Recall Number
    Z-0216-2007
    Event Number
    36628
    Firm
    Welch Allyn Protocol, Inc
    FEI Number
    3023750
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 22, 2006
    Posted
    November 28, 2006
    Terminated
    August 2, 2011
    Address
    8500 Sw Creekside Pl, Beaverton, OR, 97008

    Description

    Propaq LT vital signs monitor, Model 802LTRN

    Reason

    Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT.

    Action

    A letter dated October 22, 2006 was sent to customers between October 25-27,2006. The letter advised of the problem and requested the customer contact the firm to arrange for return of the monitor to be serviced. The customer will be provided with a temporary replacement. The dealers were requested to notify their customers.

    Distribution

    Devices were distributed to hospitals/medical centers and dealers worldwide.

    Quantity

    total of both models 1031