BEUDAMED
    FDA Recall Terminated

    ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.

    Recall: Z-0930-2013 · Initiated January 18, 2013

    Recall

    Recall Number
    Z-0930-2013
    Event Number
    64231
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 18, 2013
    Posted
    March 9, 2013
    Terminated
    July 16, 2013
    Address
    685 E Middlefield Rd, Mountain View, CA, 94043-4045

    Description

    ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.

    Reason

    On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.

    Action

    Siemens sent a Customer Safety Advisory notification letter to Siemens Service Personnel on January 18, 2013 and which would be provided to all affected sites during their visit to correct the problem. The notification identified the product, the problem and the action to be taken. The local Customer Service Engineer will perform the test at their site. If the system passes the test, no further action is required. If the ABVS pod fails the inspection, the Service Engineer will correct the sharp edge. For questions regarding this recall call 650-694-5398.

    Distribution

    Worldwide Distribution - USA including WV and OH; Internationally to Australia, Austria, Bahrain, Belgium, Brazil, China (P.R.) Estonia, France, Germany, Greece, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Macedonia, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Qatar, Rep of Korea, Romania, Sweden, Taiwan, Thailand, Turkey, Unite Arab Emirates, United Kingdom and Venezuela.

    Quantity

    214 affected devices