BEUDAMED
    FDA Recall Terminated

    Life Pulse High Frequency Ventilator (HFV)

    Recall: Z-0893-06 · Initiated April 4, 2005

    Recall

    Recall Number
    Z-0893-06
    Event Number
    33938
    Firm
    Bunnell, Inc.
    FEI Number
    3032745446
    Product Code
    LSZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 4, 2005
    Posted
    May 23, 2006
    Terminated
    November 27, 2007
    Address
    436 Lawndale Dr, Salt Lake City, UT, 84115-2917

    Description

    Life Pulse High Frequency Ventilator (HFV)

    Reason

    Potential loss of air flow or change in cycling of the ventilator. Valve Drive Regulator Board may not function properly at elevated temperatures. The increase in temperature could cause a reduction of power, causing the solenoid in the valve to function sporadically.

    Action

    Notified consignees by letter on 04/04/2005.

    Distribution

    Nationwide, Military medical center, Canada, and Czech Republic

    Quantity

    297 units