BEUDAMED
    FDA Recall Terminated

    Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00

    Recall: Z-1333-04 · Initiated June 8, 2004

    Recall

    Recall Number
    Z-1333-04
    Event Number
    29233
    Firm
    Welch Allyn Protocol, Inc
    FEI Number
    3023750
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 8, 2004
    Posted
    August 10, 2004
    Terminated
    June 21, 2006
    Address
    8500 SW Creekside Pl, Beaverton, OR, 97008-7107

    Description

    Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00

    Reason

    Potential speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts.

    Action

    The firm contacted their customers and their distributors customers via letters dated June 8, 2004 through July 9, 2004. The letters instruct their customers to verify speaker functionality. If the customers do not hear two quick beeps or there is static then they have a faulty speaker. The letters instruct them to stop using the monitor and contact Welch Allyn to have the monitor repaired. If the monitor continues to emit two quick beeps their customers are to contact Welch Allyn to have the monitor repaired as soon as it is convenient. The customers are to verify the two beeps prior to each use. The letter dated June 8, 2004 went to only a couple of direct customers. The remaining letters dated June 14, 2004, June 23, 2004, June 30, 2004 and July 9, 2004 went to direct customers, distributors and distributors'' end user customers.

    Distribution

    Welch Allyn distributes product to hospitals, physicians and distributors nationwide and internationally.

    Quantity

    1828 units