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U.S. Department of Health and Human Services

Class 2 Device Recall Villa Sistemi Medical S.P.A Juno DRF

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  Class 2 Device Recall Villa Sistemi Medical S.P.A Juno DRF see related information
Date Initiated by Firm December 27, 2016
Create Date March 09, 2017
Recall Status1 Terminated 3 on March 09, 2021
Recall Number Z-1427-2017
Recall Event ID 76367
510(K)Number K050190  
Product Classification Table, radiologic - Product Code KXJ
Product Juno DRF; Model: 709020

Product Usage:
General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Code Information Serial Numbers: 10110770 11030805 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 15121505 16011512 16021514 16021517 16021518 16041533 16121595 
Recalling Firm/
Manufacturer		 Villa Sistemi Medicali S.P.A.
Via delle Azalee 3
Buccinasco Italy
For Additional Information Contact Ernesto Filizzola
203-2628836
Manufacturer Reason
for Recall		 Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Customers were notified of the recall via DHL or similar mail service. The letter identified the affected product, problem and actions to be taken.
Quantity in Commerce 65 devices in total
Distribution US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, PA, Puerto Rico, TN, TX, UT, and W.I
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KXJ and Original Applicant = VILLA SISTEMI MEDICALI S.P.A.
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