BEUDAMED
    FDA Recall Terminated

    Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray System, Model Number: 4466033. Indended use: X-Ray, Fluoroscopic, Image-intensified.

    Recall: Z-0189-2010 · Initiated September 23, 2009

    Recall

    Recall Number
    Z-0189-2010
    Event Number
    53494
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 23, 2009
    Posted
    November 12, 2009
    Terminated
    January 12, 2010
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray System, Model Number: 4466033. Indended use: X-Ray, Fluoroscopic, Image-intensified.

    Reason

    possible injury to hand/fingers

    Action

    Siemens Medical Solutions USA, Inc. issued a "Customer Safety Advisory Notice" dated September 11, 2009 to inform customers of the potential hazard to patients when using the Siregraph CF system. For further information, contact Siemens at 1-610-448-4500.

    Distribution

    Nationwide Distribution -- FL, IL, MI, PA and TX.

    Quantity

    14 units