BEUDAMED
    FDA Enforcement Class II Terminated

    Artis Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic procedures.

    Recall: Z-2305-2018 · Reported July 4, 2018

    Enforcement

    Recall Number
    Z-2305-2018
    Event ID
    80286
    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 4, 2018
    Initiation Date
    May 1, 2018
    Classification Date
    June 27, 2018
    Termination Date
    May 16, 2019
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Artis Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic procedures.

    Reason

    After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.

    Code Info

    123008 123010

    Distribution

    Worldwide distribution. US nationwide including Puerto Rico, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Myanmar, Netherlands, New Zealand, Norway, China, Paraguay, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.

    Quantity

    2