Device Recall Kodak DirectView DR 7500 System with motorized Wall Stand (WS)

  • Modelo / Serial
    Catalog Numbers: 8551046, 8791345, 1333483, 8649253, 8864605, 1155118, 1295088, 1666700, 1845122, 1671841, 8245607, 8531675, 8966780; Service Code: 8087
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) including states of: CA, CO, FL, GA, IL,IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI; and internationally to: Australia Belgium, Canada, China, Finland, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    DR 7500 with FF WS || These products are permanently installed diagnostic x-ray systems 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 DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Carestream Health, Inc., 1049 Ridge Rd W, Rochester NY 14615-2731
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA