Events

Rappel de Device Recall Carestream Health DRXRevolution Mobile 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
    69826
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0800-2015
  • Date de mise en oeuvre de l'événement
    2014-11-25
  • Date de publication de l'événement
    2014-12-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131774
  • 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, mobile - Product Code IZL
  • Cause
    While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. carestream has identified an issue related to the drx-revolution mobile x-ray system in which bolts that secure the x-ray tube assembly/boom to the device mounting block may break. it has been determined that this issue is a result of an improperly assembled part which holds the x-ray.
  • Action
    The firm, Carestream, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 11/20/2014 to US Consignees/customers via Certified Mail on 11/25/2014. Foreign accounts will be notified as soon as possible. The letter described the product, problem and actions to taken. The customers were instructed if they observe a loosened boom to follow the procedure for turning the system off; stop using the device and contact Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis; Outside of the U.S., call your local Service support number. Carestream Health Service representative will contact all customers to schedule a visit to inspect the DRX-Revolution Mobile X-Ray System. If a repair is required it will be completed by a Carestream Field Engineer. If you have any questions, contact the Regulatory Affairs Manager at 585-627-8230 or Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis.

Device

Device Recall Carestream Health DRXRevolution Mobile XRay System
  • Modèle / numéro de série
    Serial Numbers 101 to 764
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, PALESTINE, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, and UNITED KINGDOM.
  • Description du dispositif
    DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. || The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor, imaging display and software for acquiring medical diagnostic images outside of a standard x-ray room. The DRX-Revolution Mobile X-Ray System has a motor for driving the system so that the operator does not have to push the system, but can walk behind the system while it is moving from one location to another.
  • Manufacturer
    Carestream Health Inc

Manufacturer

Carestream Health Inc
  • Adresse du fabricant
    Carestream Health Inc, 150 Verona St, Rochester NY 14608-1733
  • Société-mère du fabricant (2017)
    ONEX Corp
  • Source
    USFDA