BEUDAMED
    FDA Recall Terminated

    Sienet Cosmos. Radiological Image Processing. Model number 10018971

    Recall: Z-0092-06 · Initiated September 22, 2005

    Recall

    Recall Number
    Z-0092-06
    Event Number
    33843
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 22, 2005
    Posted
    October 28, 2005
    Terminated
    August 23, 2006
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    Sienet Cosmos. Radiological Image Processing. Model number 10018971

    Reason

    reference lines appear above actual position

    Action

    The company has issued a Customer Safety Advisory dated 9/22/05 via certified mail to the affected customers per Update Instructions CN038/05/S. The letter informs customers of the issue and also provides customer with instruction to avoid its occurrence.

    Distribution

    The product was shipped to medical facilities in CA, CO, FL, IA, KS, LA, MD, MI, MO, NC, and PA.

    Quantity

    64 units