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U.S. Department of Health and Human Services

Class 2 Device Recall Villa Sistemi Medical S.P.A Apollo

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  Class 2 Device Recall Villa Sistemi Medical S.P.A Apollo 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-1428-2017
Recall Event ID 76367
510(K)Number K050190  
Product Classification Table, radiologic - Product Code KXJ
Product Apollo; Models: 9784000131
9784000231
9784020131
9784020231
9784100231
9784120131
9784120231
9784130131

Product Usage:
General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
Code Information Serial Numbers: 06100127 06110138 07010149 07020158 07020163 07020165 07030171 07040206 09010566 09090605 10100752 11100873 15041446 
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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