BEUDAMED
    FDA Recall Terminated

    AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.

    Recall: Z-0032-05 · Initiated July 9, 2004

    Recall

    Recall Number
    Z-0032-05
    Event Number
    29826
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 9, 2004
    Posted
    October 22, 2004
    Terminated
    September 13, 2005
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.

    Reason

    possible error calculating valve area with the AXIOM Sensis

    Action

    The recalling firm has issued a Customer Advisory to the affected customers per Update Instructions AX053/04/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.

    Distribution

    The product was shipped to one government account in KY and 87 medical facilities in AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, NE, NY, OH, OK, PA, SC, TX, VA, WA, and WV.

    Quantity

    143 units