Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Villa Sistemi Medical S.P.A Apollosee related information
Date Initiated by FirmDecember 27, 2016
Create DateMarch 09, 2017
Recall Status1 Terminated 3 on March 09, 2021
Recall NumberZ-1428-2017
Recall Event ID 76367
510(K)NumberK050190 
Product Classification Table, radiologic - Product Code KXJ
ProductApollo; 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 ContactErnesto 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
ActionCustomers 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 Commerce65 devices in total
DistributionUS 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 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KXJ
-
-