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U.S. Department of Health and Human Services

Class 2 Device Recall Juno DRF

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  Class 2 Device Recall Juno DRF see related information
Date Initiated by Firm February 19, 2016
Create Date January 20, 2017
Recall Status1 Open3, Classified
Recall Number Z-1063-2017
Recall Event ID 73459
510(K)Number K050190  
Product Classification Table, radiologic - Product Code KXJ
Product Juno DRF; Model: 709020

Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Code Information 10110770 11030805 11030806 11070845 11070848 11070849 11090864 11110900 12020978 12020982 12030999 12041003 12061014 12061018 12061020 12081040 12091074 12101104 12121186 12121187 13031215 13101263 14021301 14031313 14041321 14051332 14071353 14081359 14091368 14091371 14121400 14121403 15021426 15031440 15041444 15091473 15091478 15101484 15101487 
Recalling Firm/
Manufacturer		 Villa Radiology Systems LLC
91 Willenbrock Rd Ste B1
Oxford CT 06478-1036
For Additional Information Contact Walter Schneider
203-262-8836
Manufacturer Reason
for Recall		 The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.
FDA Determined
Cause 2		 Device Design
Action Consignees were notified of the recall via letter starting on 2/19/16. The letter explains the issue and actions to be taken by the consignee and manufacturer.
Quantity in Commerce 66 distributed in US
Distribution AL AZ CA CO CT DC FL IA IL IN LA MA MD MI MN MO MS NJ NY OH PA Puerto Rico TN TX UT WI
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 = KXJ and Original Applicant = VILLA SISTEMI MEDICALI S.P.A.
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