BEUDAMED
    FDA Recall Terminated

    Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735

    Recall: Z-0138-06 · Initiated October 5, 2005

    Recall

    Recall Number
    Z-0138-06
    Event Number
    33921
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 5, 2005
    Posted
    November 15, 2005
    Terminated
    August 7, 2007
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735

    Reason

    If the recommended workflow is not followed and the worksheets are printed after moving the patient table out of isocenter, the offset values will be incorrect. This could result in a biopsy being performed at an incorrect location and presents the possibility of an inconclusive diagnosis. calculation of offset values for the breast biopsy aiming device may be incorrect

    Action

    The recalling firm issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions MR034/05/S. The letter re-emphasizes the importance of printing the offset values on the worksheet prior to moving the patient table and in accordance with the User's Manual.

    Distribution

    The product was shipped to medical facilities in CA, FL, IL, MD, MN, NM, OH, OR, RI, and WI.

    Quantity

    16 units