Events

Rappel de Device Recall Juno DFR Xray 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
    70241
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1079-2015
  • Date de mise en oeuvre de l'événement
    2014-12-14
  • Date de publication de l'événement
    2015-03-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132618
  • 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
    The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality.
  • Action
    Planned Action by the firm: 1. You will send out a customer notification letter that identified the software corrective actions and that indicates that these corrective actions will be provided to the end-user free of charge. 2. You will implement a corrective software patch so that kV and mA manual adjustments from the generator console are inhibited, and consequently no high-level control modality is allowed. In AERC, high-level control is already disabled. A Field Service Engineer is to implement the software patch according to the corrective action plan 1. 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 The system shall be modified upgrading the generator power firmware which will inhibit the high-level control bringing the system into compliance. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. You will implement the corrective software patch to inhibit high-level control according to the corrective action plan by June 22, 2015. For further questions please 203.262-8836

Device

Device Recall Juno DFR Xray system
  • Modèle / numéro de série
    P/N 709020
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of: AZ, AL, CA, CO, CT, DC, FL, IA, IL, IN, MI, MD, MS, MA, MO, NY, OH, PA, UT, TN and TX.
  • Description du dispositif
    Juno DFR X-ray system
  • 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