BEUDAMED
    FDA Enforcement Class II Terminated

    Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.

    Recall: Z-2127-2020 · Reported June 3, 2020

    Enforcement

    Recall Number
    Z-2127-2020
    Event ID
    85572
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2020
    Initiation Date
    April 17, 2020
    Classification Date
    May 26, 2020
    Termination Date
    August 25, 2020
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355, United States

    Description

    Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.

    Reason

    The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.

    Code Info

    Serial Numbers: 11200 13288 13259 12339 13241 10019 12377 13219 12946 13232 13045 12618 12972 40109 40110 40073 40057 40013 40082 40093 40078 40107 40108 40111 40120 40126 40134 40135 40104 40074 40095 40076 40080 40058 40077 40081 40055 40054 40075 40125 40113 40102 40071 40061 40094 40124 40070 40103 40118 40119 40121 40084 40122 40123 40083 40062 40130 40116

    Distribution

    US Nationwide Distribution to states of: AR, AZ, CA, FL, IL, IN, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OH, OK, SC, TN, TX, UT, VA, WA, and Puerto Rico.

    Quantity

    58