BEUDAMED
    FDA Recall Terminated

    Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator

    Recall: Z-0515-06 · Initiated December 28, 2005

    Recall

    Recall Number
    Z-0515-06
    Event Number
    34391
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 28, 2005
    Posted
    February 14, 2006
    Terminated
    August 7, 2007
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator

    Reason

    Failure to generate an alarm when an unintended disconnection occurrs

    Action

    Recalling firm has issued a medical device recall letter to consignees to the attention of the Director, Neonatal Intensive Care Unit via Certified Mail to alert them of additional monitoring requirements if a PEEP setting of less than 2.5 mbar is used

    Distribution

    Product was shipped to medical facilities nationwide

    Quantity

    2261 units