Events

Rappel de Device Recall Kodak DirectView DR 7500 Diagnostic 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 Carestream Health, Inc..

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
    68727
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2177-2014
  • Date de mise en oeuvre de l'événement
    2014-07-09
  • Date de publication de l'événement
    2014-08-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128573
  • 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
    System, x-ray, stationary - Product Code KPR
  • Cause
    An on-site evaluation of the equipment parts that attach the beta assembly (x-ray tube and collimator) to the over head tube crane (otc) telescope was completed by carestream health (csh) service engineering. inspection of these parts revealed that the tab on the lock washer was not bent into the lock nut recess and because the beta assembly detached from the otc telescope, the lock nut was not sufficiently tightened.
  • Action
    Carestream will notify all DR 7500 customers of the issue and schedule a Field Engineer to inspect and repair the system if required. Specific instructions (Service Modification) for the inspection and repair will followed by the Carestream Field Engineer in order to complete the correction. Documented evidence of the Field Engineer visit will be noted in the Carestream service engineering record for each affected system. Carestream estimates that the plan of correction will be completed within 2-4 weeks

Device

Device Recall Kodak DirectView DR 7500 Diagnostic XRay System
  • Modèle / numéro de série
    The device can be tracked according to service code. The service code for the DR 7500 system is 8087.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of (United Kingdom, United Arab Emirates, Turkey, Taiwan, Switzerland, Sweden, Spain, South Africa, Portugal, Poland, Oman, New Zealand, Netherlands, Kuwait, Italy, Israel, Hong Kong, Germany, France, Finland, Denmark, Dubai, Czech Republic, China, Korea, Belgium, Australia, and Amsterdam.
  • Description du dispositif
    Kodak DirectView DR 7500 Diagnostic X-Ray System || Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
  • Manufacturer
    Carestream Health, Inc.

Manufacturer

Carestream Health, Inc.
  • Adresse du fabricant
    Carestream Health, Inc., 1049 W Ridge Rd, Rochester NY 14615-2731
  • Société-mère du fabricant (2017)
    ONEX Corp
  • Source
    USFDA