BEUDAMED
    FDA Enforcement Class II 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 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1958-2015
    Event ID
    71270
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2015
    Initiation Date
    May 5, 2015
    Classification Date
    July 2, 2015
    Termination Date
    January 13, 2017
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406, United States

    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.

    Code Info

    Model Number of device 10308191, serial numbers: 11032 11044 11005 10115 11056 10057 10076 10019 10021 10035 10037 10073 11074 11075 11077 11083 10078 11066 11067 11013 10063 10082 11094 10089 11080 11009 11018 11082 10058 10098 11015 11016 11038 10096 10116 11035 11064

    Distribution

    Nationwide Distribution

    Quantity

    37