BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 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-1958-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1958-2020
    Event ID
    85553
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2020
    Initiation Date
    April 20, 2020
    Classification Date
    May 11, 2020
    Termination Date
    May 10, 2021
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355, United States

    Description

    Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 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

    Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from the X10 connector

    Code Info

    Serial Numbers: 40057 40047 40048 40107 40108 40111 40120 40126 40134 40135 40032 40104 40075 40102 40124 40070

    Distribution

    US Nationwide distributions.

    Quantity

    16 units