Events

Rappel de Device Recall Kodak Direct View DR3000 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
    38248
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0717-2007
  • Date de mise en oeuvre de l'événement
    2007-03-06
  • Date de publication de l'événement
    2007-07-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53238
  • 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
    X Ray System - Product Code KPR
  • Cause
    The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. this results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21code of federal regulations (cfr).
  • Action
    On 3/06/07, Eastman Kodak notified CDRH of its proposed Corrective Action Plan (CAP). The CAP was approved by CDRH under the following conditions: (1) Kodak will visit each user facility, and apply dial indicator labels to the collimator knobs, apply a field size label to the collimator housing, and verify that each system complies with the field indication performance standard. (2) Kodak will prepare adequate instructions for the assembly/installation and testing of the dial indicators labels and field size labels. These instructions are to be furnished to all owners of the Kodak Direct View DR3000 Systems. (3) Kodak will supplement the Kodak DR3000 system product report with a copy of the adequate instructions. (4) Kodak will perform 100% verification of the recall effectiveness. (5) Kodak will not charge for the corrections and will reimburse the owner for any out-of-pocket expenses. (6) Kodak will notify the manufacturer of the Ralco 302 ACS collimators, Ralco, that the collimator is noncompliant with the performance standard.

Device

Device Recall Kodak Direct View DR3000 System
  • Modèle / numéro de série
    Serial Numbers DR30001001, DR30001004, DR30001006, DR30001014, DR30001016, DR30001017, DR30001020, DR30001021, DR30000032.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    FL, NY, MO, MI, TX, and Canada
  • Description du dispositif
    Kodak Direct View DR3000 System, Stationary X-ray System, Catalog #s 655-1345, 655-1386.
  • Manufacturer
    Carestream Health, Inc.

Manufacturer

Carestream Health, Inc.
  • Adresse du fabricant
    Carestream Health, Inc., 1049 West Ridge Road, Rochester NY 14615
  • Source
    USFDA