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U.S. Department of Health and Human Services

Class 2 Device Recall Vision (Vision C, Vision U, and Vision V)

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  Class 2 Device Recall Vision (Vision C, Vision U, and Vision V) see related information
Date Initiated by Firm April 05, 2018
Create Date May 15, 2018
Recall Status1 Open3, Classified
Recall Number Z-1882-2018
Recall Event ID 79848
510(K)Number K160620  
Product Classification System, x-ray, stationary - Product Code KPR
Product Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4

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
Code Information US Systems: System SN VC17J-02002, Column SN BA-215-1800-862-1-3 0019; System SN VC17F-01002, Column SN BA-215-1800-862-1-3 0035; System SN VC17C-01002, Column SN BA-215-1800-862-1-3 0031;   International Systems: System SN VC17J-02002, Column SN BA-215-1800-862-1-3 0034; System SN VC17I-01002, Column SN BA-215-1500-792-1 0016; System SN VC17G-02002, Column SN BA-215-1800-862-1-3 0023; System SN VC16K-01002, Column SN BA-215-1800-862-1-3 0032;
Recalling Firm/
Manufacturer
Visaris DOO
Batajnicki Drum 10 Deo 1B
Belgrade
For Additional Information Contact
239-234-1735
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Other
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.
Quantity in Commerce 8 devices (US), 14 devices (international)
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = VISARIS D.O.O. BELGRADE
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