BEUDAMED
    FDA Recall Terminated

    Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560.

    Recall: Z-1745-2011 · Initiated March 20, 2009

    Recall

    Recall Number
    Z-1745-2011
    Event Number
    52904
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 20, 2009
    Posted
    March 23, 2011
    Terminated
    April 1, 2011
    Address
    1230 Shorebird Way P.O. Box 7393, Mountain View, CA, 94043

    Description

    Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560.

    Reason

    Screen Image Quality. An assembly issue on SwiftLink connectors may cause reduced/degraded image quality when using ACUSON AcuNav ultrasound catheter transducers.

    Action

    Siemens Field correction was initiated on 3/20/2009. A device correction letter was distributed to all affected users, with a description of the problem and its corrective actions. Siemens service personnel will make a site visit.

    Distribution

    Distribution in US and Internationally.

    Quantity

    21 units