BEUDAMED
    FDA Enforcement Class II Terminated

    CIOS ALPHA; image intensified fluoroscopic x-ray system

    Recall: Z-0118-2016 · Reported November 4, 2015

    Enforcement

    Recall Number
    Z-0118-2016
    Event ID
    72138
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 4, 2015
    Initiation Date
    August 17, 2015
    Classification Date
    October 23, 2015
    Termination Date
    December 5, 2016
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    CIOS ALPHA; image intensified fluoroscopic x-ray system

    Reason

    patient procedure interruption due to a potential system failure

    Code Info

    model #10308191 with serial numbers: Serial 11032 10073 11132 11044 11005 10115 11056 10057 10076 10019 10035 11074 11075 11077 11083 11124 10078 11119 11103 11105 11013 10021 10037 10063 11106 10082 11098 11094 10089 11080 11009 11018 11082 10058 10098 11120 11134 11015 11016 11038 10116 11035 11107 11064

    Distribution

    Nationwide Distribution.

    Quantity

    44