BEUDAMED
    FDA Recall Terminated

    Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflurane.

    Recall: Z-0201-2007 · Initiated September 15, 2006

    Recall

    Recall Number
    Z-0201-2007
    Event Number
    36189
    Firm
    Datex Ohmeda, Inc
    FEI Number
    2183066
    Product Code
    CAD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 15, 2006
    Posted
    November 21, 2006
    Terminated
    May 25, 2007
    Address
    3030 Ohmeda Drive PO Box 7550, zip 53707-7550, Madison, WI, 53707-7550

    Description

    Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflurane.

    Reason

    There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6 Plus Desflurane Vaporizer.

    Action

    An Urgent Medical Device Correction letter dated September 15, 2006, was sent to affected customers. The letter describes the issue, states that a GE representative will contact affected accounts to arrange for the vaporizer exchange at no charge.

    Distribution

    Nationwide and Canada.

    Quantity

    93