BEUDAMED
    FDA Recall Terminated

    Magnetom Avanto. Magnetic Resonance Imaging System. Model number 7391167

    Recall: Z-1528-05 · Initiated August 12, 2005

    Recall

    Recall Number
    Z-1528-05
    Event Number
    33308
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LNN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 12, 2005
    Posted
    September 9, 2005
    Terminated
    July 19, 2006
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    Magnetom Avanto. Magnetic Resonance Imaging System. Model number 7391167

    Reason

    there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore

    Action

    The recalling firm issued via certified mail a Customer Safety Advisory to the affected customers per Update Instructions MR031/05/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.

    Distribution

    The products were shipped to medical facilities and MRI facilities nationwide.

    Quantity

    209 units