BEUDAMED
    FDA Recall Terminated

    10041461 ACUSON S2000, manufactured by Siemens Medical Solutions, Mountain View, CA. Intended for Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/Gyn, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    Recall: Z-1006-2011 · Initiated October 2, 2009

    Recall

    Recall Number
    Z-1006-2011
    Event Number
    53780
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 2, 2009
    Posted
    February 1, 2011
    Terminated
    March 29, 2011
    Address
    1230 Shorebird Way P.O. Box 7393, Mountain View, CA, 94043

    Description

    10041461 ACUSON S2000, manufactured by Siemens Medical Solutions, Mountain View, CA. Intended for Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/Gyn, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    Reason

    ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.

    Action

    The firm's Customer Safety Advisory notice was mailed to all affected customers. The letter describes when the malfunction occurs and the potential risk. It also recommended that users collect corresponding evidence with spectral waveforms that would confirm or deny findings based on ECG, in order to avoid potential risks for misdiagnosis. The firm planned to exchange the faulty hardware component in the system. Customers would be contacted to schedule for the hardware exchange. Questions regarding this issue should be directed to the local service support person.

    Distribution

    Worldwide Distribution

    Quantity

    67 units total