Events

Recall of Device Recall Villa Sistemi Medical S.P.A Apollo

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-1428-2017
  • 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=152982
  • 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 Apollo
  • Model / Serial
    Serial Numbers: 06100127 06110138 07010149 07020158 07020163 07020165 07030171 07040206 09010566 09090605 10100752 11100873 15041446
  • 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
    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.
  • 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