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U.S. Department of Health and Human Services

Class 2 Device Recall Apollo

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 Class 2 Device Recall Apollosee related information
Date Initiated by FirmFebruary 19, 2016
Create DateJanuary 20, 2017
Recall Status1 Open3, Classified
Recall NumberZ-1064-2017
Recall Event ID 73459
510(K)NumberK050190 
Product Classification Table, radiologic - Product Code KXJ
ProductApollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Code Information 06040078 07030172 06090116 06110138 07010149 07020158 07020162 07020163 07020165 07030168 07030171 07040206 09090605 10100752 06060086 06100127 09010566 08020473 11100873 15041446 
Recalling Firm/
Manufacturer		 Villa Radiology Systems LLC
91 Willenbrock Rd Ste B1
Oxford CT 06478-1036
For Additional Information ContactWalter 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
ActionConsignees 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 Commerce66 distributed in US
DistributionAL 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 CycleTPLC 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) Database510(K)s with Product Code = KXJ
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