BEUDAMED
    FDA Recall Terminated

    SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.

    Recall: Z-1411-2009 · Initiated April 23, 2009

    Recall

    Recall Number
    Z-1411-2009
    Event Number
    51886
    Firm
    Respironics, Inc.
    FEI Number
    2518422
    Product Code
    FLS
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    April 23, 2009
    Posted
    May 19, 2009
    Terminated
    October 19, 2011
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517

    Description

    SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.

    Reason

    Audible alarm failure.

    Action

    A notification letter dated April 23, 2009 was issued to consignees informing them of the issue. Consignees were instructed to locate the affected units in their inventory and return them to Philips Children's Medical Ventures-Youngwood Service. Any units that were shipped by consignees to their customers are to be retrieved and returned to Respironics. Consignees were also instructed to complete the enclosed Business Reply Form and Serial Number Reconciliation List and fax to Stericycle at 888-345-5369 or email to [email protected]. For questions and additional information about the recall, contact Stericycle Customer Service by calling at 888-345-4630.

    Distribution

    Nationwide and Canada.

    Quantity

    4,992 units