Events

Rappel de Juno DRF System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Villa Radiology Systems LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    66024
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2160-2013
  • Date de mise en oeuvre de l'événement
    2013-08-02
  • Date de publication de l'événement
    2013-09-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-07-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121286
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Table, radiologic - Product Code KXJ
  • Cause
    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
  • Modèle / numéro de série
    PN 709020
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Villa Radiology Systems LLC, 91 Willenbrock Rd Ste B1, Oxford CT 06478-1036
  • Société-mère du fabricant (2017)
    Villa Radiology Systems Llc
  • Source
    USFDA