BEUDAMED
    FDA Enforcement Class II Terminated

    Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures.

    Recall: Z-2308-2018 · Reported July 4, 2018

    Enforcement

    Recall Number
    Z-2308-2018
    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 zee biplane, Material no. 10094141, 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

    153992 154616 154551 154536 154096 154532 154157 154571 154074 154012 154612 153274 154090 154567 154480 154093 154502 154408 153987 154509 154079 154462 154098 154073 154076 153959 154653 154671 154556 153869 154633 154058 154155 154453 154579 154034 154560 154596 153708 153248 154048 153903 153819 154087 154606 154604 154581 154423 154546 154052 154501 154514 154562 154056 153999 154631 154089 154476 131020 154584 154610 153607 153886 154576 154602 154572 154564 153744

    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

    68