BEUDAMED
    FDA Recall Terminated

    MAMMOMAT Inspiration Full field digital mammographic x-ray system

    Recall: Z-0523-2012 · Initiated September 15, 2011

    Recall

    Recall Number
    Z-0523-2012
    Event Number
    60423
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    MUE
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    September 15, 2011
    Posted
    January 11, 2012
    Terminated
    March 5, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    MAMMOMAT Inspiration Full field digital mammographic x-ray system

    Reason

    Lowering the swivel arm with "object table" while an operator's or patient's body parts are underneath the "object table" may cause the "object table" to collide with and injure the operator or patient. Therefore attention should be paid when adjusting "object table" height to avoid a possible risk of injury to the operator or the patient. The movement of the swivel arm may also cause an injur

    Action

    Siemens Medical Solutions USA, Inc sent a Safety Advisory Notice dated January 8, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The notification included an Addendum to the User Manual. We appreciate your understanding and cooperation with this safety advisory and ask you to immediately instruct your operating personnel accordingly. Please ensure that this safety advisory is placed in the System's Operator Manual. Your operating personnel should maintain awareness over an appropriate defined period. Further questions please call (610) 219-4834.

    Distribution

    Nationwide Distribution including the states of FL, MD, MI, NE, NY, NC, ND, OH, and SC.

    Quantity

    12