Events

Recall of Vision (Vision C, Vision U, and Vision V)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Visaris DOO.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79848
  • Event Risk Class
    Class 2
  • Event Number
    Z-1880-2018
  • Event Initiated Date
    2018-04-05
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163733
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, stationary - Product Code KPR
  • 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.
  • Action
    Notification letters instruct users to perform the following actions: System end users should: Sign and return the Acknowledgement Form (part of this document).  allow Visaris authorized service engineers access to perform the scheduled upgrade and refresher user training  Read and familiarize themselves with the current user manual for Vision C devices and safety guidelines provided therein. Within the next four weeks Visaris will prepare and deliver an improved version of the elevation column mechanism for the Vision C devices to all relevant authorized distributors and service organizations. Visaris distributors will get in touch with you to initiate and agree a schedule of the field upgrade. Visaris engineers will at scheduled times upgrade the column mechanisms, including complete site acceptance and additional safety testing on all upgraded devices. During this activity users will be provided with the latest version of user manual and re-fresher system use training. This notice and relevant end user action information needs to be passed on to all system end user organizations. Please acknowledge receipt of this notification and maintain awareness of this notice and resulting actions for a period of three months to ensure effectiveness of the upgrade actions. For further questions, please call (239) 234-1735.

Device

Vision (Vision C, Vision U, and Vision V)
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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
  • Manufacturer
    Visaris DOO

Manufacturer

Visaris DOO
  • Manufacturer Address
    Visaris DOO, Batajnicki Drum 10 Deo 1B, Belgrade
  • Source
    USFDA