Events

Recall of Device Recall Villa Sistemi Medical S.P.A Juno DRF

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Villa Sistemi Medicali S.P.A..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76367
  • Event Risk Class
    Class 2
  • Event Number
    Z-1427-2017
  • Event Initiated Date
    2016-12-27
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152981
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Table, radiologic - Product Code KXJ
  • Reason
    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.
  • 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.

Device

Device Recall Villa Sistemi Medical S.P.A Juno DRF
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product Description
    Juno DRF; Model: 709020 || Product Usage: || General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
  • Manufacturer
    Villa Sistemi Medicali S.P.A.

Manufacturer

Villa Sistemi Medicali S.P.A.
  • Manufacturer Address
    Villa Sistemi Medicali S.P.A., Via delle Azalee 3, Buccinasco Italy
  • Manufacturer Parent Company (2017)
    Villa Sistemi Medicali Spa
  • Source
    USFDA