BEUDAMED
    FDA Recall Terminated

    Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00

    Recall: Z-0538-04 · Initiated December 31, 2003

    Recall

    Recall Number
    Z-0538-04
    Event Number
    28003
    Firm
    Welch Allyn Protocol, Inc
    FEI Number
    3023750
    Product Code
    DSI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 31, 2003
    Posted
    February 13, 2004
    Terminated
    January 6, 2005
    Address
    8500 SW Creekside Pl, Beaverton, OR, 97008-7107

    Description

    Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00

    Reason

    Potential failure to audibly alarm due to speaker hardware component failure.

    Action

    The firm sent a letter dated December 31, 2003 instructing their customers to install an audio cable from the CPU to the Flat Panel Monitor to provide redundant speaker capability. The audio cable and installation instructions were included in the letter. The letter also included a Correction Response Form which customers should fill out upon completion of correction.

    Distribution

    The firm distributes the product nationwide and internationally.

    Quantity

    233 devices