BEUDAMED
    FDA Recall Terminated

    Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375.

    Recall: Z-0302-2007 · Initiated November 17, 2006

    Recall

    Recall Number
    Z-0302-2007
    Event Number
    36856
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 17, 2006
    Posted
    December 19, 2006
    Terminated
    November 19, 2008
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375.

    Reason

    Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient.

    Action

    The recaling firm issued a recall letter to the US customers 11/17/2006 via certified mail. An authorized service representative will inspect each potentially affected unit. If a unit is found to have an affected docking station, the unit will be repaired or replaced free or charge. Notification to international customers will occur through the international subsidiaries.

    Distribution

    Nationwide

    Quantity

    23,345 units - 4336 US