BEUDAMED
    FDA Recall Terminated

    Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical

    Recall: Z-0177-2008 · Initiated July 28, 2007

    Recall

    Recall Number
    Z-0177-2008
    Event Number
    44926
    Firm
    Oridion Capnography Inc
    FEI Number
    3006678365
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 28, 2007
    Posted
    November 28, 2007
    Terminated
    September 8, 2008
    Address
    160 Gould St, Needham Heights, MA, 02494-2313

    Description

    Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical

    Reason

    Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.

    Action

    Oridion sent Dear Customer letters dated, August 21, 2007, informing users that a new monitor with the improved handle will be shipped by August 31, 2007.

    Distribution

    Nationwide Distribution- including states of AZ, CA, FL, MA, MO, OH, TX, WA, and WI,

    Quantity

    21