BEUDAMED
    FDA Recall Terminated

    Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected sub-components Numbers: (1) 10434968, Boom Welding (for S/Ns 250157, 250162, 250163, 250164, 250166, 250167 and 250169); (2) 10434969, Arm Welding (for S/N's 250171, 250173, 250177); Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CA The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging the breast allows volumetric acquisition of the breast image. It provides the operator with the option of using a controlled user independent automated scan motion. The resulting 3D display information enables comprehensive image review by the medical professional. In particular, the coronal plane is scanned, which is not easily accessible with hand-held ultrasound transducers.

    Recall: Z-2150-2011 · Initiated March 28, 2011

    Recall

    Recall Number
    Z-2150-2011
    Event Number
    58504
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    March 28, 2011
    Posted
    May 6, 2011
    Terminated
    May 6, 2011
    Address
    1230 Shorebird Way P.O. Box 7393, Mountain View, CA, 94043

    Description

    Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected sub-components Numbers: (1) 10434968, Boom Welding (for S/Ns 250157, 250162, 250163, 250164, 250166, 250167 and 250169); (2) 10434969, Arm Welding (for S/N's 250171, 250173, 250177); Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CA The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging the breast allows volumetric acquisition of the breast image. It provides the operator with the option of using a controlled user independent automated scan motion. The resulting 3D display information enables comprehensive image review by the medical professional. In particular, the coronal plane is scanned, which is not easily accessible with hand-held ultrasound transducers.

    Reason

    The weld connecting the ABVS arm to the system base has the potential to fail, causing the arm to fall off of the unit.

    Action

    Siemens Medical Solutions USA, Inc. initiated the recall via phone calls and e-mail on March 28, 2011, to all affected customers, informing them of the affected product and providing instructions on the recall. Three units S/N 250171, 250173, and 250177 were to be removed and shipped back to Siemens. Siemens Service personnel were to be dispatched to the customer sites to perform validated stress test on units S/N 250157, 250162, 250163, 250164, 250166, 250167, and 250169 at customer sites. For questions regarding this recall call 650-694-5993.

    Distribution

    Worldwide Distribution - USA, Portugal, Germany, Russia, Estonia, Brazil, France, and Saudi Arabia.

    Quantity

    10