BEUDAMED
    FDA Recall Terminated

    Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes.

    Recall: Z-0052-2014 · Initiated July 10, 2013

    Recall

    Recall Number
    Z-0052-2014
    Event Number
    65812
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 10, 2013
    Posted
    October 23, 2013
    Terminated
    November 25, 2013
    Address
    685 E Middlefield Rd, Mountain View, CA, 94043-4045

    Description

    Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes.

    Reason

    Software issue results in inaccurate 3D image may result in ablation in wrong location.

    Action

    Siemens sent an Customer Safety Advisory Notification letter to all affected customers on July 10, 2013.The letter identified the product the problem and the action needed to be taken by the customer Letters provide steps to mitigate the risk and inform users that a software fix will be installed as soon as it is available. Siemens Service Engineers will contact all locations to arrange installation once fix is available. All personnel who use the ACUSON should be notified of the issue. Update September 17, 2013 : After discussion with CDRH, Siemens revised their letter to state that procedures using the ACUSON SC2000 system with BioSense Webster CARTO 3 equipped with CARTOSOUND Module and SoundSTAR Catheter should not be performed until the users system has been updated with the software upgrade that resolves the issue. For further questions please call (650) 694-5398.

    Distribution

    Worldwide Distribution - US (nationwide) including the states of IL, PA, AZ, OR, OH, NY, CO, TX and CA., and the countries of France, Germany, Japan, Portugal, Saudi Arabia, Taiwan and Turkey.

    Quantity

    26 units