Events

Recall of Juno DRF System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Villa Radiology Systems LLC.

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
    66024
  • Event Risk Class
    Class 2
  • Event Number
    Z-2160-2013
  • Event Initiated Date
    2013-08-02
  • Event Date Posted
    2013-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121286
  • 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
    It has been discovered that the air kerma rate information is inconsistent in continuous fluoro modes 30x30 (12"x12") and 15x15 (6"x6). this could result in a deviation of the displayed values of air kerma rate and cumulated air kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 cfr 1020.32(k)(6.
  • Action
    The Center for Devices and Radiological Health (CDRH) understands that the Villa Sistemi Medicali (U.S. Agent: Villa Radiology Systems) is responsible for the correction of all 22 noncompliant units distributed within the U.S. Should the CAP prove ineffective in bringing the noncompliant unit(s) in the field into compliance with the applicable performance standard, the CDRH can require more stringent measures to obtain compliance. The system will be modified by upgrading the generator power firmware, which will bring Juno DRF x-ray system into compliance. You provided a verification and validation test report (Juno DRF System AK fix-DAM Prom V&V; Test Report) to FDA demonstrating that these proposed upgrades addressed the problem. Field service engineers will schedule an appointment with customers to install the new software. 2. The customer notification letter (URGENT: Electronic Product Radiation Warning), dated August 02, 2013, includes the statement that "the manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you." 3. The CAP will be completed within a six month timeframe (by March 1, 2014). 4. The manufacturer will notify the Secretary on monthly basis providing progress with the field correction. CDRH approves the CAP subject to the following conditions: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. For further questions please call (203) 262-8836.

Device

Juno DRF System
  • Model / Serial
    PN 709020
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of AZ, MI, IN, UT, CT, AL, NY, PA, IL, MD, CA, MA, IA, OH, MS and MO.
  • Product Description
    Juno DRF System. Mobile X-ray system || These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
  • Manufacturer
    Villa Radiology Systems LLC

Manufacturer

Villa Radiology Systems LLC
  • Manufacturer Address
    Villa Radiology Systems LLC, 91 Willenbrock Rd Ste B1, Oxford CT 06478-1036
  • Manufacturer Parent Company (2017)
    Villa Radiology Systems Llc
  • Source
    USFDA