BEUDAMED
    FDA Recall Terminated

    Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients

    Recall: Z-1958-2015 · Initiated May 5, 2015

    Recall

    Recall Number
    Z-1958-2015
    Event Number
    71270
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 5, 2015
    Posted
    July 2, 2015
    Terminated
    January 13, 2017
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients

    Reason

    under certain circumstances the Cios Alpha system may freeze during a procedure.

    Action

    Siemens sent an Safety Advisory Notice dated May 5 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were alerting them about the issue and risks involved. Customers were provided work-around instructions until a software fix is released. For further questions please call (610) 219-6300.

    Distribution

    Nationwide Distribution

    Quantity

    37