BEUDAMED
    FDA Enforcement Class II Terminated

    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics

    Recall: Z-1880-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1880-2018
    Event ID
    79848
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Visaris DOO
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 23, 2018
    Initiation Date
    April 5, 2018
    Classification Date
    May 15, 2018
    Termination Date
    September 19, 2019
    Address
    Batajnicki Drum 10 Deo 1B, Belgrade, N/A

    Description

    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics

    Reason

    A failure of the tube arm suspension is possible while the tube arm height is being adjusted. During tube height adjustment there is a small probability of failure of both the primary and redundant holding mechanisms, causing uncontrollable descent of the tube arm and a potential risk of injury to the patient.

    Code Info

    System SN VC16B-02002, Column SN BA-215-1800-862-1-30008; System SN VC15L-02002, Column SN BA-215-1800-862-1-30015; System SN VC15L-01002, Column SN BA-215-1800-862-1-30011; System SN VC15J-01002, Column SN BA-215-1500-792-10001; System SN VC15I-02001, Column SN BA-215-1800-862-1-30006

    Distribution

    Worldwide Distribution - US Distribution to the states of : FL, LA, MD, MS, NJ, and NY., and to the countries of : Czech Republic, Germany, Serbia, Switzerland, Taiwan, and United Kingdom.

    Quantity

    8 devices (US), 14 devices (international)